Device brand name · Intraocular lens

Isymm Aspheric Intraocular Lens: medical device reports filed with FDA

202 reports name it, 2009–2015. Manufacturer given most often on reports: Hoya Surgical Optics. Product code HQL.

Read first · FDA's statement on these data

Adverse event reports submitted to FDA do not undergo extensive validation or verification. Therefore, a causal relationship cannot be established between product and reactions listed in a report. While a suspected relationship may exist, it is not medically validated and should not be the sole source of information for clinical decision making or other assumptions about the safety or efficacy of a product. Additionally, it is important to remember that adverse event reports represent a small percentage of total usage numbers of a product. Common products may have a higher number of adverse events due to the higher total number of people using the product. openFDA, FDA

FDA adds: "Although MDRs are a valuable source of information, this passive surveillance system has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data. In addition, the incidence or prevalence of an event cannot be determined from this reporting system alone due to potential under-reporting of events and lack of information about frequency of device use." And: "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices."

Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated.

Not medical advice. This site counts what was reported to FDA. Questions about a medicine or device belong with a pharmacist or clinician.

202
device reports naming the brand: 0% of all MAUDE reports · about 12 a year; 0
reports, 12 months to August 2026: 0 in the 12 months before; 95%
classified as malfunction: 52.8% across the product code; 0%
classified as death, as reported: 0 reports · not verified by FDA

202 medical device reports received by FDA name the brand "Isymm Aspheric Intraocular Lens" (intraocular lens); the manufacturer given most often on reports is Hoya Surgical Optics; received from May 2009 to May 2015. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.

0 reports arrived in the 12 months to August 2026, and none in the 12 months before. FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases. The event types recorded are malfunction (95%), injury (4%) and other (1%); across all intraocular lens reports (product code HQL) death is recorded in 0% and malfunction in 52.8%. Event type is the reporter's classification of the report, not a verified outcome.

The device problems coded most often are break (28.7%), detachment of device component (28.2%) and torn material (22.8%). The patient problems coded most often are visual impairment, endophthalmitis and failure of implant. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data."

Reports by month, five years

No report naming Isymm Aspheric Intraocular Lens was received in the five years to August 2026; the latest was received in May 2015.

By year received

Event type and report source

Event type, as classified on the report

Death0%0

Injury4%8

Malfunction95%192

Other1%2

Not given0%0

Who filed the report

Manufacturer report100%202

Voluntary report0%0

User facility report0%0

Distributor report0%0

Not given0%0

Grey bar: all 79,755 reports carrying product code HQL. Event type is the filer's classification and is not verified by FDA.

Device problems coded

Device problem (FDA code)	Reports	Share	Share across product code
Breakthe device broke	58	28.7%	9.8%
Detachment of device component	57	28.2%	0.5%
Torn material	46	22.8%	1.5%
Scratched material	12	5.9%	3.9%
Bent	10	5%	0.5%
Crackthe device cracked	10	5%	2.8%
Device operates differently than expectedthe device behaved unexpectedly	8	4%	1%
Improper or incorrect procedure or method	6	3%	0.3%
Insufficient device problem information	6	3%	2.3%
Difficult to insertthe device was hard to insert	5	2.5%	1.5%
Failure to unfold or unwrap	3	1.5%	0.7%
Malposition of device	3	1.5%	1.2%
Material deformation	3	1.5%	0.5%
Component missing	2	1%	0.1%
Difficult to fold, unfold or collapse	2	1%	0.7%
Difficult to position	2	1%	0.3%
Material twisted/bent	2	1%	1.1%
Peeled/delaminated	2	1%	0%
Burst container or vessel	1	0.5%	0%
Fitting problem	1	0.5%	0.1%

FDA's device problem codes as entered on the report; one report can carry several. Generic codes such as "no apparent adverse event" are left out.

Patient problems coded

Patient problem (FDA code)	Reports	Share
Visual impairmentreduced vision	3	1.5%
Endophthalmitisinfection inside the eye	2	1%
Failure of implant	1	0.5%
Perforation	1	0.5%

Patient problem codes are present mainly in reports filed since 2019 and are often blank.

In context

Measure	Isymm Aspheric Intraocular Lens	Product code HQL	All MAUDE reports
Reports	202	79,755	26,136,888
Share of that pool	—	0.3%	0%
Classified as death, per 1,000 reports	0	0	9
Classified as injury	4%	42.8%	36.2%
Classified as malfunction	95%	52.8%	62.3%
Filed by the manufacturer	100%	98.2%	94.9%

Shares are of reports, not of devices in use. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data."

Other brands with product code HQL

Brand	Reports	Latest 12 months	Classified as death
Acrysof	9,161	0	0%
Tecnis Simplicity	5,310	1,217	0%
Tecnis Iol	5,901	715	0%
Tecnis	3,082	0	0.1%
Tecnis Itec Preloaded 1-Piece Iol	2,435	0	0%
AcrySof IQ Natural Singlepiece IOL	2,424	118	0%
Clareon IOL with the AutonoME Delivery System	2,276	864	0%
Tecnis 1-Piece	2,259	0	0%
enVista Intraocular Lens	2,163	36	0%
Hydroview Intraocular Lens	2,067	0	0%
Acrysof Restor	3,801	0	0%
Acrysof Iq Toric	1,905	0	0%
AcrySof Multipiece IOL	1,619	298	0%
Silicone Advanced Optic-Violet Shield	1,413	0	0%
AcrySof Singlepiece IOL	1,211	131	0%

Ordered by report count for navigation only. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data." FDA also states that "common products may have a higher number of adverse events due to the higher total number of people using the product."

Questions about Isymm Aspheric Intraocular Lens reports

How many FDA reports name Isymm Aspheric Intraocular Lens?

202 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 0 in the latest 12 months.

What kinds of events are reported?

malfunction (95%), injury (4%) and other (1%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.

What device problems are coded?

break (28.7%), detachment of device component (28.2%), torn material (22.8%), scratched material (5.9%) and bent (5%). These are FDA's device problem codes as entered on the report.

Who files these reports?

manufacturer reports (100%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.

Do these reports show that Isymm Aspheric Intraocular Lens was at fault?

No. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data." FDA adds that "a causal relationship cannot be established between product and reactions listed in a report."

How do I report a problem with a medical device?

Through FDA MedWatch (Form FDA 3500 for health professionals and consumers), or to the manufacturer. See the guide on how to report.

Where this comes from. Counts are built from the openFDA Device Adverse Event (MAUDE) bulk export released 28 Sep 2026, which holds reports FDA received through 31 Aug 2026. Brand, generic and manufacturer names are as written on the reports; product code names come from FDA's device classification. A report counts here when any device it lists carries this brand name after punctuation and capitalisation are normalised. No report narrative, lot number, patient detail or reporter identity is published. See the methodology and sources; FDA's record is authoritative, and corrections are handled within five working days.

Drug data (FAERS) through 30 Jun 2026; device data (MAUDE) through 31 Aug 2026. Not medical advice.