Aaris Acrylic Intraocular lens(IOL) EC-3 PAL (UDI 00884872025275)Recalls & reported problems
Aaren Scientific Inc. · Class 3 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00884872025275), received between Jul 22, 2016 and Jul 22, 2016 — classified as 1 injury.
The most frequently reported specific device problem is “Detachment Of Device Component” (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
- Detachment Of Device Component1
Patient problems
- Visual Impairment1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJul 22, 2016Detachment Of Device Component; Detachment Of Device Component
ADDITIONAL INFORMATION WAS RECEIVED AND STATED THAT A FOLLOW-UP PROCEDURE WAS PERFORMED ON (B)(6) 2016. THE PATIENT HAD THE SCLERAL FIXATED AND ANOTHER LENS GLUED USING TISSEEL GLUE. THE PATIENT REPORTEDLY IS DOING GREAT AND THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA. NO ADDITIONAL INFORMATION HAS BEEN RECEIVED.
Patient problems: Visual Impairment
MAUDE report 5814730 ↗
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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