SIL. COATED I/A 45 STELLARIS 12/B 85910STRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 04058935000363), received between Nov 13, 2023 and May 13, 2025 — classified as 5 injuries, 1 malfunction.

The most frequently reported specific device problem is “Defective Component” (4 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

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 13, 2025Particulates; Particulates

  A USER FACILITY REPORTED THAT DURING CATARACT SURGERY, THE SURGEON NOTICED A WHITE SUBSTANCE ON THE TIP OF AN I/A 45 DEGREE HANDPIECE 85910ST. CURRENTLY, IT IS NOT KNOWN IF THERE IS ANY HARM TO THE PATIENT. THE DOCTOR WILL BE WATCHING THIS PATIENT CAREFULLY IN FOLLOW UP VISITS. THERE WERE NO DELAYS IN SURGERY NOR ADDITIONAL ANESTHESIA PROVIDED TO THE PATIENT. THE SURGERY WAS COMPLETED. THREE PHOTOS WERE PROVIDED, AND THE SUBSTANCE WAS SENT TO THE LAB FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22015485 ↗
• InjuryOct 3, 2024Defective Component; Defective Component

  IT WAS REPORTED BY THE USER FACILITY AT THE VA IN (B)(6) THAT THE METAL TIP PROTRUDED OUT OF THE SILICONE AND MAY HAVE BEEN RESPONSIBLE FOR A PUNCTURE WOUND. THE PATIENT HAD A PUNCTURE TO THE BAG DURING A SURGERY ON (B)(6) 2024, WITH DR. (B)(6); OD (PHACO IOL WITH ANTERIOR VITRECTOMY). UPON ENTRY INTO THE INCISION, THE METAL TIP PROTRUDED OUT OF THE SILICONE SHEATH AND THE PUNCTURED THE POSTERIOR CAPSULE, RESULTING IN THE NEED TO PERFORM ANTERIOR VITRECTOMY. THE HANDPIECE WAS DISCARDED. ONE SUTURE WAS PLACED DUE TO ENLARGEMENT OF THE WOUND TO ACCOMMODATE A 3 PIECE IOL IN THE SULCUS DUE TO THE POSTERIOR CAPSULAR TEAR AND VITREOUS PROLAPSE. SURGERY WAS LONGER THAN USUAL. AFTER WE STARTED TOPICAL MOXIFLOXACIN, PREDNISOLONE AND DICLOFENAC DUE TO HIGH RISK OF ENDOPHTHALMITIS AND CYSTOID MACULA EDEMA FROM POSTERIOR CAPSULAR TEAR. PATIENT HAD A FOLLOW UP THREE DAYS AFTER SURGERY AND IS DOING WELL, VISION IS IMPROVING.

  Patient problems: Capsular Bag Tear

  MAUDE report 20361010 ↗
• InjurySep 4, 2024Defective Component; Defective Component

  IT WAS REPORTED BY THE USER FACILITY IN THE UNITED KINGDOM THAT THE SLEEVES ARE MOVING AND THAT HAD CAUSED A POTERIOR CAPSULE RUPTURE. PROCEDURE CARRIED OUT SUCCESSFULLY WITH NO MEDICAL INTERVENTION REQUIRED. THE PATIENT HAD A SUCCESSFUL PROCEDURE AND IS HAPPY WITH OUTCOME.

  Patient problems: Capsular Bag Tear

  MAUDE report 20139357 ↗
• InjuryMay 23, 2024Material Too Soft/Flexible; Material Too Soft/Flexible

  THE USER FACILITY REPORTED THAT THE CAPSULEGUARD WAS BUNCHING UP CAUSING IT TO GRAB THE BAG. THE SURGEON HAD TO PERFORM A VITRECTOMY, REQUIRING ADDITIONAL CASE TIME AND STITCHES TO CLOSE THE WOUND.

  Patient problems: Capsular Bag Tear

  MAUDE report 19381894 ↗
• InjuryNov 13, 2023Product Quality Problem; Defective Component; Product Quality Problem; Defective Component

  A USER FACILITY IN THE UNITED KINGDOM REPORTED THAT DURING SURGERY THE SLEEVE IS COLLAPSING AND STICKING THE INNER ASPIRATION TUBE AT THE CORNEAL INCISION SITE. THERE WAS A SUDDEN ADVANCEMENT AND A POSTERIOR CAPSULE RUPTURE OCCURRED DURING IRRIGATION AND ASPIRATION. THE PROCEDURE WAS CHANGED AND A VITRECTOMY WAS PERFORMED ON THE PATIENTS EYE. SURGERY WAS INCREASED 15-30 MINUTES.

  Patient problems: Capsular Bag Tear

  MAUDE report 18122154 ↗
• InjuryNov 13, 2023Product Quality Problem; Defective Component; Product Quality Problem; Defective Component

  A USER FACILITY IN THE UNITED KINGDOM REPORTED THAT DURING SURGERY THE SLEEVE IS COLLAPSING AND STICKING THE INNER ASPIRATION TUBE AT THE CORNEAL INCISION SITE. THERE WAS A SUDDEN ADVANCEMENT AND A POSTERIOR CAPSULE RUPTURE OCCURRED DURING IRRIGATION AND ASPIRATION. THE PROCEDURE WAS CHANGED AND A VITRECTOMY WAS PERFORMED ON THE PATIENTS EYE. SURGERY WAS INCREASED 15-30 MINUTES.

  Patient problems: Capsular Bag Tear

  MAUDE report 18118852 ↗