Elastic UV-Absorbing Silicone Posterior Chamber Intraocular Lens - Toric Optic AA4203TL (UDI 00841542100700)Recalls & reported problems
Staar Surgical Company · Diopter: 17.5 SE/2.0 Toric; Overall Diameter (Length): 11.2 mm (Longer Haptic) · 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 00841542100700), received between Jun 5, 2017 and Jun 5, 2017 — classified as 1 malfunction.
The most frequently reported specific device problem is “Device Operates Differently Than Expected” (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 Operates Differently Than Expected1
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.
MalfunctionJun 5, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected
THE REPORTER STATED THAT AA4203TL, 17.5SE/2.0 DIOPTER, SILICONE SINGLE PIECE INTRAOCULAR LENS WAS IMPLANTED ON (B)(6) 2016. IT WAS EXPLANTED DURING THE SAME SURGERY DUE TO A TEAR IN THE LENS. THE BACKUP LENS WAS IMPLANTED WITH NO ISSUES. THERE WAS NO REPORTED ENLARGEMENT OF THE INCISION AND NO PATIENT INJURY. THE REPORTER STATED THAT THE NURSE FELT LIKE THE DOCTOR TORE THE LENS WHEN HE WAS PUSHING IT OUT OF THE INJECTOR AND THE CAUSE WAS USER ERROR.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6613239 ↗
Other Lens, Intraocular, Toric Optics devices
- TECNIS IOL ZCT150Johnson & Johnson Surgical Vision, Inc. · LENS, INTRAOCULAR, TORIC OPTICS1 recall7 reports
- Clareon CNWTT0Alcon Laboratories, Inc. · LENS, INTRAOCULAR, TORIC OPTICS43 reports
- Clareon CNWTT0Alcon Laboratories, Inc. · LENS, INTRAOCULAR, TORIC OPTICS36 reports
- Clareon CNWTT0Alcon Laboratories, Inc. · LENS, INTRAOCULAR, TORIC OPTICS32 reports
- Clareon CNWTT0Alcon Laboratories, Inc. · LENS, INTRAOCULAR, TORIC OPTICS30 reports
- Clareon CNWTT0Alcon Laboratories, Inc. · LENS, INTRAOCULAR, TORIC OPTICS29 reports
- Clareon CNWTT0Alcon Laboratories, Inc. · LENS, INTRAOCULAR, TORIC OPTICS21 reports
- TECNIS IOL DIU150Johnson & Johnson Surgical Vision, Inc. · LENS, INTRAOCULAR, TORIC OPTICS19 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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