Elastimide UV-Absorbing Silicone Posterior Chamber Intraocular Lens AQ2010V (UDI 00841542101226)Recalls & reported problems
Staar Surgical Company · Diopter: 5.0 Three Piece · Class 3 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00841542101226), received between Feb 6, 2016 and Apr 6, 2016 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Break” (2 reports).
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
- Break2
Patient problems
- No Code Available1
- No Consequences Or Impact To Patient1
- Visual Disturbances1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryApr 6, 2016Break; Break
THE REPORTER INDICATED THE SURGEON INSERTED AN AQ2010V +05.00 DIOPTER THREE PIECE SILICONE LENS. THE HAPTIC BROKE DURING INSERTION INTO THE PATIENT'S LEFT EYE. LENS WAS REMOVED WITH NO PATIENT INJURY. NO BACKUP LENS WAS AVAILABLE AT THE TIME. A LENS WAS IMPLANTED TWO WEEKS LATER. CAUSE OF BROKEN HAPTIC IS UNKNOWN.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 5553045 ↗MalfunctionFeb 6, 2016Break; Break
THE REPORTER INDICATED THE SURGEON INSERTED AN AQ2010V +05.00 DIOPTERTHREE PIECE SILICONE LENS. THE LENS TORE UPON INSERTION INTO THE PATIENT'S EYE. THE INCISION WAS ENLARGED TO REMOVE THE LENS AND ONE SUTURE WAS USED TO CLOSE THE WOUND. AT THIS TIME NO LENS WAS IMPLANTED, THEY DID NOT HAVE A BACKUP LENS.THIS LENS WAS USED AS A PIGGYBACK LENS. THE REPORTED WAS INFORMED THAT USING LENS AS A PIGGYBACK IS CONSIDERED OFF-LABEL USE. TWO WEEKS LATER ON (B)(6) 2016, A LENS WAS IMPLANTED.
Patient problems: No Code Available; Visual Disturbances
MAUDE report 5414890 ↗
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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