Device manufacturer, as written on reports

Bausch & Lomb: medical device reports filed with FDA

17,224 reports name it as the manufacturer of the device involved, 1996–2026.

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.

17,224
reports naming it as manufacturer: 0.1% of all MAUDE reports; 35
reports, 12 months to August 2026: 36 in the 12 months before; 58.2%
classified as malfunction: 62.3% across all reports; 0%
classified as death, as reported: 0.9% across all reports

17,224 medical device reports received by FDA give Bausch & Lomb as the manufacturer of the device involved, 0.1% of the MAUDE database, from May 1996 to August 2026. Manufacturer names are as written on the report; subsidiaries and spelling variants may appear as separate names.

35 reports arrived in the 12 months to August 2026, close to the 36 of 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 (58.2%), injury (40.9%) and other (0.6%). 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
Peroxiclear Hydrogen Peroxide Solution	Accessories, soft lens products	2,844	0	0%
Hydroview Intraocular Lens	Intraocular lens	1,644	0	0%
enVista Intraocular Lens	Intraocular lens	1,538	36	0%
Silicone Advanced Optic-Violet Shield	Intraocular lens	1,413	0	0%
Silicone Advance Optic Lens	Intraocular lens	1,113	0	0%
Easy Load Inserter	Folders and injectors, intraocular lens (iol)	594	0	0%
Soflex Three-Piece Foldable Lens	Intraocular lens	484	0	0%
Envista Iol	Intraocular lens	474	0	0%
Renu With Moistureloc Multi-Purpose Solution	Accessories, soft lens products	386	0	0%
Soflex Silicone Square Edge Foldable Lens	Intraocular lens	353	0	0%
Silicone Advanced Optic Lens	Intraocular lens	250	0	0%
Renu With Moisture Loc	Accessories, soft lens products	171	0	0%
Micro Incision Vacuum Pack	Unit, phacofragmentation	160	0	0%
Renu Multiplus Multi-Purpose Solution	Accessories, soft lens products	156	0	0%
Ez-28 Delivery System	Folders and injectors, intraocular lens (iol)	133	0	0%
Crystalens Accommodating Iol	Lens, intraocular, accommodative	103	0	0%
Crystalens Intraocular Lens	Lens, intraocular, accommodative	88	0	0%
Crystalens	Intraocular lens	70	0	0%
Stellaris Pc Vision Enhancement System	Unit, phacofragmentation	44	1	0%
Stellaris Vision Enhancement System	Unit, phacofragmentation	44	3	0%
Millennium Microsurgical System	Unit, phacofragmentation	42	0	0%
Sofport AO Intraocular Lens	Intraocular lens	37	5	0%
Trulign Toric Posterior Chamber Iol	Lens, intraocular, toric optics	22	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
HQL	Intraocular lens	8,616	50%
LPN	Accessories, soft lens products	4,170	24.2%
HQC	Unit, phacofragmentation	1,513	8.8%
MSS	Folders and injectors, intraocular lens (iol)	855	5%
NAA	Lens, intraocular, accommodative	294	1.7%
HQE	Instrument, vitreous aspiration and cutting, ac-powered	239	1.4%
LPL	Lenses, soft contact, daily wear	211	1.2%
LPM	Lenses, soft contact, extended wear	211	1.2%
HNO	Keratome, ac-powered	207	1.2%
KYB	Lens, guide, intraocular	194	1.1%

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%1

Injury40.9%7,040

Malfunction58.2%10,029

Other0.6%98

Not given0.3%56

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?

17,224 reports through August 2026, 35 of them in the latest 12 months.

Which of its brands appear most often?

Peroxiclear Hydrogen Peroxide Solution (2,844), Hydroview Intraocular Lens (1,644), enVista Intraocular Lens (1,538), Silicone Advanced Optic-Violet Shield (1,413) and Silicone Advance Optic Lens (1,113).

Which device types does it report on?

intraocular lens (50%), accessories, soft lens products (24.2%), unit, phacofragmentation (8.8%) and folders and injectors, intraocular lens (iol) (5%).

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.