Reported Reactions

Devices › Intraocular lens

Device brand name · Intraocular lens

Hydroview Intraocular Lens: medical device reports filed with FDA

2,067 reports name it, 2000–2022. Manufacturer given most often on reports: Bausch & Lomb. Product code HQL.

2,067
device reports naming the brand
0% of all MAUDE reports · about 78 a year
0
reports, 12 months to August 2026
0 in the 12 months before
18.6%
classified as malfunction
52.8% across the product code
0%
classified as death, as reported
0 reports · not verified by FDA

2,067 medical device reports received by FDA name the brand "Hydroview Intraocular Lens" (intraocular lens); the manufacturer given most often on reports is Bausch & Lomb; received from January 2000 to October 2022. 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 injury (77.9%), malfunction (18.6%) and other (3.4%); 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 explanted (58%), calcified (53.1%) and lens, opacification of (34%). The patient problems coded most often are surgical procedure, visual impairment and calcium deposits/calcification. 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

012Sep 2021: 0Oct 2021: 0Nov 2021: 0Dec 2021: 02022Jan 2022: 0Feb 2022: 2Mar 2022: 1Apr 2022: 0May 2022: 1Jun 2022: 0Jul 2022: 0Aug 2022: 0Sep 2022: 0Oct 2022: 1Nov 2022: 0Dec 2022: 02023Jan 2023: 0Feb 2023: 0Mar 2023: 0Apr 2023: 0May 2023: 0Jun 2023: 0Jul 2023: 0Aug 2023: 0Sep 2023: 0Oct 2023: 0Nov 2023: 0Dec 2023: 02024Jan 2024: 0Feb 2024: 0Mar 2024: 0Apr 2024: 0May 2024: 0Jun 2024: 0Jul 2024: 0Aug 2024: 0Sep 2024: 0Oct 2024: 0Nov 2024: 0Dec 2024: 02025Jan 2025: 0Feb 2025: 0Mar 2025: 0Apr 2025: 0May 2025: 0Jun 2025: 0Jul 2025: 0Aug 2025: 0Sep 2025: 0Oct 2025: 0Nov 2025: 0Dec 2025: 02026Jan 2026: 0Feb 2026: 0Mar 2026: 0Apr 2026: 0May 2026: 0Jun 2026: 0Jul 2026: 0Aug 2026: 0

Reports by the month FDA received them. FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases.

By year received

04078142000: 20820002001: 1682002: 32420022003: 8142004: 33320042006: 172007: 520072009: 32010: 320102011: 52012: 3220122013: 442014: 2620142015: 342016: 1020162017: 102018: 1120182019: 62020: 920202022: 5

Event type and report source

Event type, as classified on the report

Death0%0
Injury77.9%1,610
Malfunction18.6%385
Other3.4%70
Not given0.1%2

Who filed the report

Manufacturer report100%2,067
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)ReportsShareShare across product code
Explanted1,19858%7.3%
Calcified1,09753.1%1.6%
Lens, opacification of70334%1.7%
Device remains implanted54526.4%4.3%
Lens replacement44921.7%4.1%
Material opacification1336.4%1.6%
Lens, cloudy241.2%0.7%
Replace241.2%1.7%
Haptic(s), broken160.8%2.7%
Other (for use when an appropriate device code cannot be identified)130.6%2.2%
Device issuea problem with the device80.4%0.2%
Foreign material70.3%0.3%
Device, removal of (non-implant)60.3%1%
Haptic(s), bent50.2%3.1%
Breakthe device broke30.1%9.8%
Tears, rips, holes in device, device material30.1%2.1%
Difficult to fold, unfold or collapse20.1%0.7%
Material separation20.1%0.1%
Mislabeled20.1%0.1%
Component missing10%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)ReportsShare
Surgical procedure1,20458.2%
Visual impairmentreduced vision41019.8%
Calcium deposits/calcification1497.2%
Blurred vision954.6%
Surgical procedure, repeated894.3%
Failure of implant512.5%
Other (for use when an appropriate patient code cannot be identified)371.8%
Surgical procedure, additional321.5%
Visual disturbances160.8%
Therapeutic response, decreased120.6%
Lens, replacement of90.4%
Eye injury60.3%
Surgical incision, enlargement of60.3%
Jaundiceyellowing of the skin or eyes50.2%
Surgical procedure aborted/stopped50.2%

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

In context

MeasureHydroview Intraocular LensProduct code HQLAll MAUDE reports
Reports2,06779,75526,136,888
Share of that pool—2.6%0%
Classified as death, per 1,000 reports009
Classified as injury77.9%42.8%36.2%
Classified as malfunction18.6%52.8%62.3%
Filed by the manufacturer100%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

BrandReportsLatest 12 monthsClassified as death
Acrysof9,16100%
Tecnis Simplicity5,3101,2170%
Tecnis Iol5,9017150%
Tecnis3,08200.1%
Tecnis Itec Preloaded 1-Piece Iol2,43500%
AcrySof IQ Natural Singlepiece IOL2,4241180%
Clareon IOL with the AutonoME Delivery System2,2768640%
Tecnis 1-Piece2,25900%
enVista Intraocular Lens2,163360%
Acrysof Restor3,80100%
Acrysof Iq Toric1,90500%
AcrySof Multipiece IOL1,6192980%
Silicone Advanced Optic-Violet Shield1,41300%
AcrySof Singlepiece IOL1,2111310%
Silicone Ultraviolet-Absorbing Posterior Chamber Three Piece Foldable Intraocula1,13800%

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 Hydroview Intraocular Lens reports

How many FDA reports name Hydroview Intraocular Lens?

2,067 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?

injury (77.9%), malfunction (18.6%) and other (3.4%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.

What device problems are coded?

explanted (58%), calcified (53.1%), lens, opacification of (34%), device remains implanted (26.4%) and lens replacement (21.7%). 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 Hydroview 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.