Collamer Ultraviolet Absorbing Posterior Chamber Intraocular Lens CQ2015A (UDI 00841542101899)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00841542101899), received between Sep 24, 2018 and Sep 26, 2019 — classified as 2 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Use of Device Problem” (2 reports).

5 other recalls cover devices cleared under the same FDA submission (P990013); they may or may not involve this specific model.

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjurySep 26, 2019Use of Device Problem; Use of Device Problem

  THE REPORTER INDICATED THE SURGEON INSERTED A CQ2015A COLLAMER THREE PIECE LENS, +15.5 DIOPTER, AND THE HAPTIC TORE. THE INCISION WAS ENLARGED AND THE LENS WAS CUT TO REMOVE FROM THE PATIENTS EYE. ANOTHER SAME MODEL LENS WAS IMPLANTED, BUT IT ALSO TORE, SEE MFR REPORT # 2023826-2019-01747. A 3RD COLLAMER THREE PIECE LENS WAS IMPLANTED SUCCESSFULLY. THE CAUSE OF THE EVENT WAS USER ERROR. AT ONE DAY POST-OP, PATIENT WAS IN SATISFACTORY CONDITION.

  Patient problems: No Code Available

  MAUDE report 9126512 ↗
• InjurySep 26, 2019Use of Device Problem; Use of Device Problem

  THE REPORTER INDICATED THE SURGEON INSERTED A CQ2015A COLLAMER THREE PIECE LENS, +15.5 DIOPTER, AND THE HAPTIC TORE. THIS IS THE 2ND LENS USED FOR THIS PATIENT THAT WAS DAMAGED AND REMOVED. SEE MFR REPORT # 2023826-2019-01746. A 3RD COLLAMER THREE PIECE LENS WAS IMPLANTED SUCCESSFULLY AND 2 SUTURES WERE REQUIRED TO CLOSE THE INCISION. THE CAUSE OF THE EVENT WAS USER ERROR. AT ONE DAY POST-OP, PATIENT WAS IN SATISFACTORY CONDITION.

  Patient problems: No Code Available

  MAUDE report 9126509 ↗
• MalfunctionNov 6, 2018No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTER INDICATED THAT A CQ2015A, +15.5 DIOPTER, INTRAOCULAR LENS TORE DURING LOADING. THERE WAS NO PATIENT CONTACT. BACKUP LENS WAS USED. THE REPORTER INDICATED THAT THE CAUSE OF THE EVENT WAS DUE TO LOADING ERROR.

  Patient problems: No Patient Involvement

  MAUDE report 8042427 ↗
• MalfunctionSep 24, 2018No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTER INDICATED THAT A HAPTIC OF A CQ2015A, +15.5 DIOPTER, INTRAOCULAR LENS BENT UPON INSERTION ON (B)(6) 2018. IMPLANTED AND REMOVED FROM EYE DURING INITIAL SURGERY WITH NO PATIENT INJURY. BACKUP LENS WAS USED AND RESOLVED PROBLEM. PATIENT IS STABLE. NO INJURY RESULTED FROM SURGERY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7903842 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P990013. One submission often covers many models, so check the product and lot details in each record.

• Z-1746-2013 · Jun 10, 2013 · Terminated
  nanoFLEX CC4204A Intraocular Lens Correct aphakia in persons 60 years of age or older in whom a cataractous lens has been removed by cataract extraction. The IOL is to be implante
• Z-1747-2013 · Jun 10, 2013 · Terminated
  Afinity CQ2015A Intraocular Lens The visual correction of aphakia in persons 60 years of age or older in whom a cataractous lens has been removed by cataract extraction.
• Z-2706-2011 · May 20, 2011 · Terminated
  Brand Name STAAR Surgical Collamer Ultraviolet-Absorbing Posterior Chamber Single Piece Foldable Intraocular Lens Common Names Collamer single piece IOL Collamer plate haptic IOL
• Z-1037-04 · Jun 17, 2004 · Terminated
  STAAR Surgical Intra Occular Lens, Collamer.
• Z-0539-04 · Feb 9, 2004 · Terminated
  Collamer UV One-Piece IntraOcular Lens. Models 4205BF and 4204BF