Elastimide UV-Absorbing Silicone Three-Piece Posterior Chamber Intraocular Lens AQ5010V (UDI 00841542101288)Recalls & reported problems
Staar Surgical Company · Diopter: 1.0 Convex/Plano; Three Piece · Class 3 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00841542101288), received between Apr 6, 2016 and Apr 6, 2016 — classified as 1 malfunction.
The most frequently reported specific device problem is “Break” (1 report).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Most reported problems
Device problems
- Break1
Patient problems
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 6, 2016Break; Break
THE REPORTER INDICATED THE SURGEON INSERTED AN AQ5010V +01.00 DIOPTER THREE PIECE SILICONE LENS. THE LENS WAS NOT FOLDED CORRECTLY DURING LOADING. THE PHYSICIAN TRIED TO REMOVE AND REFOLD THE LENS TO RELOAD, HOWEVER LENS WOULD NOT FOLD PROPERLY. WHEN THEY TRIED TO IMPLANT THE LENS, IT TORE. LENS WAS PARTIALLY IN THE EYE. LENS WAS REMOVED WITH NO PATIENT INJURY. CAUSE OF THIS INCIDENT WAS DUE TO LOADING ERROR BY THE SURGICAL TECH.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 5553062 ↗
Other Intraocular Lens devices
- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens146 reports
- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens145 reports
- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens144 reports
- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens139 reports
- TECNIS SIMPLICITY DIB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens1 recall81 reports
- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens129 reports
- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens127 reports
- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens126 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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