iSert Intraocular Lens 251 (yellow), +18.00DRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 04547480450254), received between Sep 29, 2017 and Feb 11, 2026 — classified as 3 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Break” (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

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 11, 2026Sharp Edges

  EVENT OCCURRED IN CHINA. LEADING HAPTIC REPORTED. CAPSULAR BAG TEAR RUPTURE. THE PATIENT UNDERWENT PHACOEMULSIFICATION AND INTRAOCULAR LENS IMPLANTATION UNDER TOPICAL ANESTHESIA ON (B)(6) 2026. DURING THE IMPLANTATION, THE LEADING HAPTIC OF THE INTRAOCULAR LENS TORE THE POSTERIOR CAPSULE WHILE UNFOLDING. AFTER ADJUSTING THE POSITION OF THE INTRAOCULAR LENS AND INSTILLING CARBACHOL TO CONSTRICT THE PUPIL, THE IOL WAS CENTERED IN THE CAPSULAR BAG. THE SURGERY WAS COMPLETED SMOOTHLY WITH NO ADVERSE EFFECTS. PLEASE REFER TO THE ATTACHMENT SURGICAL PICTURE. PROBLEM CODE: A051102 - SHARP EDGES.

  Patient problems: Capsular Bag Tear

  MAUDE report 24318964 ↗
• MalfunctionMay 3, 2019Failure to Eject; Failure to Eject

  INCIDENT FORM DESCRIPTION: DURING THE INSERTION OF THE LENS, THE SURGEON FOUND THE INJECTOR WAS FAULTY AND THE LENS WAS NOT COMING OUT OF THE INJECTOR AS IT SHOULD. INJECTOR/CARTRIDGE RELATED: CLOGGING. PATIENT IMPACT: ONLY LENGTHENING OF PROCEDURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8580227 ↗
• MalfunctionOct 9, 2018Break; Break

  PARTIAL SEPARATION OF PART OF THE TRAILING HAPTIC WAS NOTICED DURING IMPLANTATION. LENS HAD TO BE EXPLANTED. NEW LENS WAS IMPLANTED. SECOND IMPLANTATION WENT WELL WITHOUT HARMING THE PATIENT. PATIENT OUTCOME: NO PATIENT IMPACT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7948008 ↗
• InjuryJun 28, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PER THE OP NOTES, RECEIVED 14-JUN-2018, IT WAS REPORTED THAT: THE LENS WAS INJECTED INTO THE POSTERIOR CAPSULAR BAG, THOUGH UPON POSITIONING THE LENS, THE LENS TIPPED AND FELL INTO THE POSTERIOR SEGMENT BEFORE IT COULD BE GRASPED WITH SURGICAL INSTRUMENTS. VISCODISPERSIVE WAS INJECTED INTO THE VITREAL CAVITY TO ACT AS A BUFFER AND PREVENT ANY VITREOUS PROLAPSE. THE MAIN WOUND WAS WIDENED. A DIFFERENT LENS WAS THEN PLACED IN THE SULCUS. THE PATIENT TOLERATED THE PROCEDURE WITHOUT EVENT. PER EMAIL RECEIVED 13-JUN-2018, IT WAS REPORTED THAT: DOCTOR ADVISED THAT THEY TRIED TO PUT THE LENS IN THE BAG TO WORK AROUND THE TEAR, BUT IT SLIPPED INTO THE POSTERIOR SEGMENT. THE POSTERIOR CAPSULE WAS VIOLATED, SO THE ONE PIECE LENS COULD NOT BE IMPLANTED IN THE BAG. DOCTOR USED A THREE PIECE LENS IMPLANT AND PLACED IT IN THE SULCUS THE SAME DAY DURING SURGERY ON (B)(6) 2018.

  Patient problems: Capsular Bag Tear

  MAUDE report 7648238 ↗
• InjurySep 29, 2017Migration or Expulsion of Device

  REPORTEDLY, THE PHYSICIAN NOTICED THE LENS DECENTERED POST LENS INSERTION INTO THE PATIENT'S LEFT EYE AND SUBSEQUENTLY FOUND A POSTERIOR CAPSULE BREAK. THERE WAS ALSO VITREOUS LOSS. THE LENS WAS REMOVED AND A SULCUS LENS WAS IMPLANTED. THE SURGEON INDICATED THE CAUSE OF THE EVENT IS NOT KNOWN BUT THE LEADING HAPTIC MAY HAVE CAUSED POSTERIOR CAPSULE BREAK. THE PATIENT IS DOING WELL AND NO FURTHER TREATMENT IS ANTICIPATED AT THIS TIME.

  Patient problems: Capsular Bag Tear; Vitrectomy

  MAUDE report 6904710 ↗