Collamer Ultraviolet Absorbing Posterior Chamber Intraocular Lens CQ2015A (UDI 00841542101998)Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00841542101998), received between Nov 17, 2016 and Apr 4, 2018 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Device Operates Differently Than Expected” (7 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 4, 2018Device Operates Differently Than Expected; Device Operates Differently Than Expected

  THE REPORTER INDICATED THAT THE SURGEON ATTEMPTED TO IMPLANT A CQ2015A, +20.5 DIOPTER, INTRAOCULAR LENS IN THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2017. DURING SURGERY, THE HAPTIC WAS TORN OFF. THERE WAS NO PATIENT CONTACT WITH THE DEVICE. NO OTHER INFORMATION WAS ABLE TO BE PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7398193 ↗
• MalfunctionFeb 22, 2018Device Operates Differently Than Expected; Device Operates Differently Than Expected

  THE REPORTER INDICATED THAT DURING IMPLANTATION OF A CQ2015A , +20.5 DIOPTER, COLLAMER LENS, THE CARTRIDGE SPLIT OPEN AND THE LENS STARTED COMING OUT FROM THE SIDE OF THE CARTRIDGE. THERE WAS NO PATIENT INJURY AND THE BACK UP LENS WAS IMPLANTED WITH NO ISSUES. THE REPORTER STATED THAT THE CAUSE OF EVENT WAS DUE TO A LOADING ISSUE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7291078 ↗
• MalfunctionJan 9, 2018Device Operates Differently Than Expected; Device Operates Differently Than Expected

  THE REPORTER INDICATED THAT THE HAPTIC OF (B)(4) COLLAMER THREE PIECE LENS, +20.5 DIOPTER, TORE DURING INSERTION. IT WAS REPORTED THAT THERE WAS NO SURGICAL INTERVENTION AND NO PATIENT INJURY. THE BACK UP LENS WAS IMPLANTED WITHIN THE SAME SURGERY WITH NO ISSUES. THE REPORTER STATED THAT THE CAUSE OF THE EVENT WAS UNKNOWN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7177220 ↗
• MalfunctionDec 7, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  THE REPORTER INDICATED THAT THE HAPTIC OF A CQ2015A, +20.5 DIOPTER, INTRAOCULAR LENS GOT BENT UPON LOADING. THERE WAS NO PATIENT CONTACT WITH THE DEVICE AND THE CAUSE OF THE EVENT IS UNKNOWN. THE BACKUP LENS WAS USED AND IT WAS SUCCESSFUL. THE REPORTER WAS UNABLE TO PROVIDE ANY ADDITIONAL INFORMATION.

  Patient problems: No Patient Involvement

  MAUDE report 7095131 ↗
• MalfunctionAug 17, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  THE REPORTER INDICATED THAT A (B)(4) HAPTIC BROKE OFF LENS WHILE TRYING TO LOAD THE LENS. THE SURGEON NOTICED THE TEAR DURING LOADING (BEFORE INSERTION). THE REPORTER STATED THAT THE CAUSE OF THE LENS TEAR WAS THAT THE PRODUCT CAME DAMAGED. A BACK-UP (B)(4) LENS WAS USED ON THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6800951 ↗
• MalfunctionJun 14, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  THE REPORTER STATED THAT A CQ2015, +20.5 DIOPTER, COLLAMER THREE PIECE INTRAOCULAR LENS RIPPED DURING THE LOADING PROCESS BECAUSE OF THE INJECTOR. THE REPORTER STATED THAT THEY DISCARDED THE LENS AND RETURNED THE EMPTY BOX TO THE MANUFACTURER. THERE WAS NO PATIENT CONTACT. THE NANOPOINT INJECTOR WAS USED.

  Patient problems: No Patient Involvement

  MAUDE report 6642443 ↗
• MalfunctionMay 18, 2017Device Abrasion From Instrument Or Another Object; Device Abrasion From Instrument Or Another Object

  THE REPORTER STATED THAT A CQ2015A, +20.5 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 6576699 ↗
• MalfunctionNov 17, 2016Device Operates Differently Than Expected; Device Operates Differently Than Expected

  THE REPORTER STATED THE SURGEON ATTEMPTED TO INSERT A CQ2015A COLLAMER THREE PIECE LENS, +20.5 DIOPTER, AND THE LENS TORE. THERE WAS NO PATIENT CONTACT. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NONE HAS BEEN FORTHCOMING. IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6111720 ↗

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