Collamer Ultraviolet Absorbing Posterior Chamber Intraocular Lens CQ2015A (UDI 00841542101882)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00841542101882), received between May 17, 2017 and Dec 12, 2018 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Device Abrasion From Instrument Or Another Object” (1 report).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 12, 2018No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTER INDICATED THE SURGEON INSERTED A CQ2015A COLLAMER THREE PIECE LENS, +15.0 DIOPTER, AND THE LENS HAPTIC TORE. THE LENS WAS REMOVED DURING THE SAME SURGERY, WITH NO PATIENT INJURY. THE BACKUP LENS WAS IMPLANTED AND THE PROBLEM WAS RESOLVED. THE REPORTER INDICATED THE CAUSE OF THE EVENT WAS UNKNOWN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8158092 ↗
• MalfunctionAug 30, 2017Improper or Incorrect Procedure or Method; Device Operates Differently Than Expected; Improper or Incorrect Procedure or Method; Device Operates Differently Than Expected

  THE REPORTER INDICATED THAT AS THE SURGEON WAS ATTEMPTING TO LOAD A 13.0MM CQ2015A IMPLANTABLE COLLAMER LENS DIOPTER +15.0, THE SURGEON HAD A PROBLEM LOADING THE LENS. THE REPORTER STATED NO PATIENT INJURY. UPON LENS RETURN, THE BOX HAD THE WORDS "PATIENT CONTACT" WRITTEN ON IT. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN UNSUCCESSFUL.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6832599 ↗
• MalfunctionMay 17, 2017Device Abrasion From Instrument Or Another Object; Device Abrasion From Instrument Or Another Object

  THE REPORTER STATED THAT A CQ2015A, +15.0 DIOPTER, THREE PIECE COLLAMER LENS WAS IMPLANTED AND EXPLANTED DURING THE SAME SURGERY DUE TO A NICK IN THE OPTIC. THE NICK OCCURRED DURING THE LOADING PROCESS DUE TO THE USER NOT USING THE OPTIMAL TYPE OF FORCEPS FOR THIS TYPE OF LENS. THE REPORTER STATED THIS WAS THE FIRST TIME THE USER WAS PERFORMING A PROCEDURE FOR THIS TYPE OF LENS. THERE WAS NO ENLARGEMENT OF THE INCISION AND NO SUTURES NEEDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6574310 ↗

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-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-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-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