Reported Reactions

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FDA product code LYL · class 2 · Ophthalmic

Accessories, solution, ultrasonic cleaners for lenses: medical device reports filed with FDA

325 reports carry this product code, 1996–2026; 3 brands with a page.

325
reports with this product code
0% of all MAUDE reports
5
reports, 12 months to August 2026
6 in the 12 months before
58.5%
classified as malfunction
62.3% across all reports
0%
classified as death, as reported
0.9% across all reports

Product code LYL is FDA's classification for "Accessories, solution, ultrasonic cleaners for lenses" (ophthalmic panel), a class 2 device. 325 medical device reports carry this product code, 0% of the MAUDE database, from October 1996 to August 2026.

5 reports arrived in the 12 months to August 2026, down 17% from 6 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 (58.5%), injury (39.1%) and other (0.6%). 3 brand names with a page on this site carry this code; the brands table is 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."

Brands with this product code

BrandReportsLatest 12 monthsClassified as deathClassified as malfunction
Allergan Cup16800%96%
Renu With Moistureloc Multi-Purpose Solution4300%0%
Renu Multiplus Multi-Purpose Solution1900%43.5%

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."

Manufacturers named

Manufacturer (as written on reports)ReportsShare
Bausch & Lomb10933.5%
Allergan257.7%
Bausch + Lomb144.3%
Ciba Vision10.3%

Reports by month, five years

023Sep 2021: 1Oct 2021: 0Nov 2021: 0Dec 2021: 02022Jan 2022: 0Feb 2022: 0Mar 2022: 0Apr 2022: 0May 2022: 0Jun 2022: 1Jul 2022: 0Aug 2022: 2Sep 2022: 0Oct 2022: 0Nov 2022: 0Dec 2022: 02023Jan 2023: 0Feb 2023: 1Mar 2023: 0Apr 2023: 0May 2023: 1Jun 2023: 0Jul 2023: 1Aug 2023: 2Sep 2023: 0Oct 2023: 0Nov 2023: 0Dec 2023: 02024Jan 2024: 0Feb 2024: 0Mar 2024: 1Apr 2024: 0May 2024: 0Jun 2024: 0Jul 2024: 0Aug 2024: 0Sep 2024: 0Oct 2024: 1Nov 2024: 3Dec 2024: 02025Jan 2025: 0Feb 2025: 1Mar 2025: 1Apr 2025: 0May 2025: 0Jun 2025: 0Jul 2025: 0Aug 2025: 0Sep 2025: 0Oct 2025: 2Nov 2025: 0Dec 2025: 02026Jan 2026: 0Feb 2026: 0Mar 2026: 0Apr 2026: 2May 2026: 0Jun 2026: 0Jul 2026: 0Aug 2026: 1

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

Event type and report source

Event type

Death0%0
Injury39.1%127
Malfunction58.5%190
Other0.6%2
Not given1.8%6

Who filed

Manufacturer report95.1%309
Voluntary report4.9%16
User facility report0%0
Distributor report0%0
Not given0%0

Grey bar: all 26,136,888 MAUDE reports.

Device problems coded

Device problem (FDA code)ReportsShare
Breakthe device broke17955.1%
Burst container or vessel17854.8%
Contamination268%
Failure to disinfect237.1%
Patient-device incompatibilitythe device did not suit the patient51.5%
Insufficient device problem information41.2%
Device misassembled during manufacturing /shipping30.9%
Patient device interaction problem30.9%
Product quality problem20.6%
Chemical problem10.3%
Component(s), broken10.3%
Defective component10.3%
Defective devicethe device was defective10.3%
Detachment of device component10.3%
Fracturea broken bone10.3%
Material fragmentation10.3%
Noise10.3%
Reactiona reaction, type not specified10.3%

Questions about accessories, solution, ultrasonic cleaners for lenses reports

What is product code LYL?

FDA's classification code for "Accessories, solution, ultrasonic cleaners for lenses", class 2, reviewed by the ophthalmic panel. Every device report carries the product code of the device involved.

How many reports carry this code?

325 reports through August 2026, 5 of them in the latest 12 months.

Which brands appear most often?

Allergan Cup (168), Renu With Moistureloc Multi-Purpose Solution (43) and Renu Multiplus Multi-Purpose Solution (19). Widely used products collect more reports because more people use them.

Can the brands table be used to rank the devices?

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." Brands differ in how many are in use, how long they have been sold and how reports are collected.

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. 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.