Device manufacturer, as written on reports

Bausch + Lomb: medical device reports filed with FDA

6,263 reports name it as the manufacturer of the device involved, 2010–2026.

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.

6,263
reports naming it as manufacturer: 0% of all MAUDE reports; 272
reports, 12 months to August 2026: 361 in the 12 months before; 32.8%
classified as malfunction: 62.3% across all reports; 0%
classified as death, as reported: 0.9% across all reports

6,263 medical device reports received by FDA give Bausch + Lomb as the manufacturer of the device involved, 0% of the MAUDE database, from March 2010 to August 2026. Manufacturer names are as written on the report; subsidiaries and spelling variants may appear as separate names.

272 reports arrived in the 12 months to August 2026, down 25% from 361 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 (67.1%) and malfunction (32.8%). Manufacturers are required to report events they learn of, so a large manufacturer with many products in use files many reports. 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."

Brands named most often

Brand	Device type	Reports	Latest 12 months	Classified as death
Crystalens Accommodating Iol	Lens, intraocular, accommodative	564	0	0%
Stellaris Vision Enhancement System	Unit, phacofragmentation	517	3	0%
enVista Intraocular Lens	Intraocular lens	514	36	0%
Stellaris Pc Vision Enhancement System	Unit, phacofragmentation	316	1	0%
Sofport AO Intraocular Lens	Intraocular lens	227	5	0%
Trulign Toric Posterior Chamber Iol	Lens, intraocular, toric optics	149	0	0%
Crystalens	Intraocular lens	123	0	0%
Crystalens Intraocular Lens	Lens, intraocular, accommodative	120	0	0%
Hydroview Intraocular Lens	Intraocular lens	94	0	0%
Envista Iol	Intraocular lens	76	0	0%
Ez-28 Delivery System	Folders and injectors, intraocular lens (iol)	62	0	0%
Silicone Advanced Optic Lens	Intraocular lens	24	0	0%
Thermage Tip	Electrosurgical, cutting & coagulation & accessories	6	0	0%
Easy Load Inserter	Folders and injectors, intraocular lens (iol)	5	0	0%
Thermage Cpt System	Electrosurgical, cutting & coagulation & accessories	5	0	0%
Renu Multiplus Multi-Purpose Solution	Accessories, soft lens products	4	0	0%
Millennium Microsurgical System	Unit, phacofragmentation	3	0	0%
Micro Incision Vacuum Pack	Unit, phacofragmentation	2	0	0%

Brands with a page on this site, 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."

Device types

Product code	Device type	Reports	Share
HQC	Unit, phacofragmentation	2,192	35%
HQL	Intraocular lens	1,566	25%
NAA	Lens, intraocular, accommodative	887	14.2%
MSS	Folders and injectors, intraocular lens (iol)	713	11.4%
MJP	Lens, intraocular, toric optics	327	5.2%
LZP	Aid, surgical, viscoelastic	108	1.7%
MFK	Lens, multifocal intraocular	104	1.7%
HNN	Knife, ophthalmic	63	1%
POE	Extended depth of focus intraocular lens	55	0.9%
HNR	Forceps, ophthalmic	32	0.5%

Reports by month, five years

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

Event type

Death0%2

Injury67.1%4,203

Malfunction32.8%2,052

Other0%1

Not given0.1%5

Grey bar: all 26,136,888 MAUDE reports. Event type is the filer's classification and is not verified by FDA.

Questions about Bausch + Lomb reports

How many FDA device reports name Bausch + Lomb as manufacturer?

6,263 reports through August 2026, 272 of them in the latest 12 months.

Which of its brands appear most often?

Crystalens Accommodating Iol (564), Stellaris Vision Enhancement System (517), enVista Intraocular Lens (514), Stellaris Pc Vision Enhancement System (316) and Sofport AO Intraocular Lens (227).

Which device types does it report on?

unit, phacofragmentation (35%), intraocular lens (25%), lens, intraocular, accommodative (14.2%) and folders and injectors, intraocular lens (iol) (11.4%).

Does a high count say something about the manufacturer?

Not by itself. Manufacturers must file a report for every event they become aware of, so report volume follows the number 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."

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. Manufacturer names are pooled after company suffixes (Inc., LLC, GmbH and similar) are dropped; names that read as a person rather than an organisation are never published. 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.