Elastimide UV-Absorbing Silicone Posterior Chamber Intraocular Lens AQ2010V (UDI 00841542100229)Recalls & reported problems
Staar Surgical Company · Diopter: 20.0 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
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00841542100229), received between Feb 17, 2016 and Oct 21, 2016 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Bent” (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
- Bent1
- Break1
- Compatibility Problem1
- Device Operates Differently Than Expected1
- Torn Material1
Patient problems
- No Code Available1
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 21, 2016Device Operates Differently Than Expected; Compatibility Problem; Torn Material; Device Operates Differently Than Expected; Compatibility Problem; Torn Material
THE REPORTER STATED THE AQ2010V SILICONE THREE PIECE LENS +20.0 DIOPTER WAS PARTIALLY INSERTED IN THE PATIENT'S EYE ON (B)(6) 2016 WHEN THE LENS WAS CLIPPED BY THE INSERTER, THE LENS WAS EXPLANTED ON (B)(6) 2016 WITHOUT PATIENT INJURY. IT WAS INDICATED THAT THE CAUSE OF THE LENS DAMAGE WAS DUE TO POSSIBLE HUMAN ERROR.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6046694 ↗MalfunctionFeb 17, 2016Bent; Break; Bent; Break
THE REPORTER STATED THE SURGEON INSERTED AN AQ2010V +20.00 DIOPTER THREE PIECE SILICONE LENS. THE HAPTIC GOT DAMAGED DURING INSERTION INTO THE PATIENT'S LEFT EYE. THE LENS WAS REMOVED AND ONE SUTURE WAS USED. THERE WAS NO PATIENT INJURY. CAUSE OF DAMAGED HAPTIC IS UNKNOWN. LENS TORE UPON INSERTION INTO THE PATIENT'S LEFT EYE. LENS WAS REMOVED WITH NO PATIENT INJURY. ANOTHER SAME MODEL AND SIZE LENS WAS IMPLANTED.
Patient problems: No Code Available
MAUDE report 5443121 ↗
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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