Collamer Ultraviolet Absorbing Posterior Chamber Intraocular Lens CQ2015A (UDI 00841542102056)Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00841542102056), received between May 18, 2017 and Sep 22, 2020 — classified as 1 injury, 5 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjurySep 22, 2020No Apparent Adverse Event; No Apparent Adverse Event

  A CQ2015A COLLAMER THREE PIECE LENS, +23.5 DIOPTER, WAS RECEIVED BY THE MANUFACTURER DAMAGED. THE REPORTER INDICATED THE LENS WAS IMPLANTED AND REMOVED DUE TO HAVING MISFIRED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NONE HAS BEEN FORTHCOMING. IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10566481 ↗
• MalfunctionApr 24, 2019No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTER INDICATED THAT ON (B)(6) 2019 A CQ2015A, +23.5 DIOPTER, INTRAOCULAR LENS TORE DURING INJECTION INTO THE EYE. THERE WAS PATIENT CONTACT (LENS TOUCHED THE EYE), "LENS WAS REMOVED WITH NO SUTURES OR WIDENED INCISION". NO PATIENT INJURY. BACKUP LENS WAS USED DURING SAME SURGERY. REPORTEDLY, "NO PATIENT CONDITION ISSUES REPORTED." CAUSE OF EVENT IS UNKNOWN.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8545453 ↗
• MalfunctionApr 24, 2019No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTER INDICATED THAT ON (B)(6) 2019 A CQ2015A , +23.5 DIOPTER, INTRAOCULAR LENS TORE DURING LOADING. THERE WAS NO PATIENT CONTACT. NO PATIENT INJURY. BACKUP LENS WAS USED DURING SAME SURGERY. REPORTEDLY, "NO PATIENT CONDITION ISSUES REPORTED."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8545018 ↗
• MalfunctionMar 27, 2019No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTER STATED "CQ2015A WAS LOADED INTO THE CQ CARTRIDGE, APPEARED TO HAVE THE TRAILING HAPTIC LOOK KINKED. IOL WAS DELIVERED ONTO STERILE TABLE AND THE TRAILING HAPTIC WAS KINKED. IT APPEARS THE MSI-TM INJECTOR ROD WAS BENT IN THE UPWARD POSITION AND THAT IS WHY THE TRAILING HAPTIC WAS KINKED. WE DID NOT HAVE THE LOT NUMBER FOR THE INJECTOR AND THE INJECTOR WAS TRASHED. NO PATIENT CONTACT WITH PRODUCT. IOL DID NOT GET IMPLANTED OR TOUCH THE PATIENT. NO PATIENT INJURY. WE GOT ANOTHER MSI-TM INJECTOR, ANOTHER CQ CARTRIDGE AND ANOTHER CQ IOL AND IT WAS SUCCESSFULLY IMPLANTED".

  Patient problems: No Patient Involvement

  MAUDE report 8458337 ↗
• MalfunctionMar 27, 2019No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTER STATED "CQ2015A WAS LOADED INTO THE CQ CARTRIDGE, APPEARED TO HAVE THE TRAILING HAPTIC LOOK KINKED. IOL WAS DELIVERED ONTO STERILE TABLE AND THE TRAILING HAPTIC WAS KINKED. IT APPEARS THE MSI-TM INJECTOR ROD WAS BENT IN THE UPWARD POSITION AND THAT IS WHY THE TRAILING HAPTIC WAS KINKED. WE DID NOT HAVE THE LOT NUMBER FOR THE INJECTOR AND THE INJECTOR WAS TRASHED. NO PATIENT CONTACT WITH PRODUCT. IOL DID NOT GET IMPLANTED OR TOUCH THE PATIENT. NO PATIENT INJURY. WE GOT ANOTHER MSI-TM INJECTOR, ANOTHER CQ CARTRIDGE AND ANOTHER CQ IOL AND IT WAS SUCCESSFULLY IMPLANTED".

  Patient problems: No Patient Involvement

  MAUDE report 8458201 ↗
• MalfunctionMay 18, 2017Device Abrasion From Instrument Or Another Object; Device Abrasion From Instrument Or Another Object

  THE REPORTER STATED THAT A CQ2015A, +23.5 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 6576005 ↗

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