Elastimide UV-Absorbing Silicone Three-Piece Posterior Chamber Intraocular Lens AQ5010V (UDI 00841542101349)Recalls & reported problems
Staar Surgical Company · Diopter: 4.0 Convex/Plano; 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 00841542101349), received between Mar 1, 2016 and Mar 24, 2016 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Device Issue” (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
- Device Issue1
- Fracture1
Patient problems
- No Consequences Or Impact To Patient2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 24, 2016Fracture; Fracture
THE REPORTER STATED THE SURGEON USED AN AQ5010V +4.00 DIOPTER THREE PIECE SILICONE LENS. AS THE SURGEON WAS GOING TO INSERT. THE LENS, THE LENS CRACKED IN THE CARTRIDGE. THE LENS WAS NOT USED. THERE WAS NO PATIENT CONTACT. THE LENS IS DEFECTIVE. ANOTHER SAME MODEL LENS WAS IMPLANTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 5525104 ↗MalfunctionMar 1, 2016Device Issue; Device Issue
THE REPORTER STATED THE SURGEON IMPLANTED AN AQ5010V +04.00 DIOPTER THREE PIECE SILICONE LENS. LENS TORE DURING INSERTION INTO THE EYE. THE LENS WAS REMOVED WITHOUT ANY INJURY TO PATIENT. ANOTHER LENS, SAME MODEL AND SIZE WAS IMPLANTED. CAUSE OF LENS TEAR WAS LOADING ERROR BY THE TECH, IT WAS THE FIRST TIME THE TECH LOADED THIS MODEL. THERE WAS NO PROBLEM LOADING THE SECOND LENS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 5472445 ↗
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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