Collamer Ultraviolet Absorbing Posterior Chamber Intraocular Lens CC4204A (UDI 00841542102353)Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00841542102353), received between Apr 4, 2018 and Mar 9, 2021 — classified as 2 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Device Operates Differently Than Expected” (3 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.

• MalfunctionMar 9, 2021Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event; Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event

  THE REPORTER INDICATED THAT A CC4204A INTRAOCULAR LENS, DIOPTER +18.0 TORE DURING INSERTION INTO THE PATIENT'S EYE. THIS OCCURRED ON (B)(6) 2021. THE LENS WAS EXPLANTED AND REPLACED WITH AN ALTERNATE LENS. REPORTEDLY, NO PATIENT INJURY OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11448820 ↗
• MalfunctionMay 1, 2019No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTER INDICATED THAT ON (B)(6) 2019 A CC4204A, +18.0 DIOPTER, INTRAOCULAR LENS TORE DURING INJECTION INTO THE EYE. THERE WAS PATIENT CONTACT (LENS TOUCHED THE EYE) WITH NO PATIENT INJURY. THE LENS WAS REMOVED AND A BACKUP LENS WAS IMPLANTED WITHIN THE SAME SURGERY, ON (B)(6) 2019. PATIENT'S CURRENT CONDITION; GOOD. CAUSE OF THE EVENT IS REPORTED AS INJECTOR FAILURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8570759 ↗
• MalfunctionMar 25, 2019No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTER INDICATED THAT A CC4204A, +18.0 DIOPTER, INTRAOCULAR LENS WAS DAMAGED DURING INSERTION INTO THE EYE. THE LENS WAS IMPLANTED AND REMOVED FROM EYE DURING INITIAL SURGERY ON (B)(6) 2019 WITH NO PATIENT INJURY. BACKUP LENS WAS IMPLANTED AND PROBLEM RESOLVED. REPORTER STATED THAT "THE CAUSE OF EVENT WAS DUE CARTRIDGE ISSUES."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8447835 ↗
• MalfunctionDec 7, 2018No Apparent Adverse Event; No Apparent Adverse Event

  A CC4204A COLLAMER SINGLE PIECE LENS, +18.0 DIOPTER, WAS RECEIVED DAMAGED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NONE HAS BEEN FORTHCOMING. IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8143311 ↗
• InjuryJul 5, 2018Device Operates Differently Than Expected; Device Operates Differently Than Expected

  THE REPORTER INDICATED THAT A CC4204A, +18.0 DIOPTER, INTRAOCULAR LENS WAS IMPLANTED INTO THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2018. ON (B)(6) 2018 THE LENS WAS REMOVED DUE TO MISPOWERED IOL, WRONG POWER FOR EYE. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NONE HAS BEEN FORTHCOMING. IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED.

  Patient problems: No Code Available

  MAUDE report 7664583 ↗
• MalfunctionJun 21, 2018Device Issue; Device Issue

  A DAMAGE CC4204A ,+18.0 DIOPTER, INTRAOCULAR LENS WAS RETURNED. A NOTE ON THE LENS PACKAGING BOX INDICATED "OPEN & NOT USED, LENS TORE". ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NON 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 7626955 ↗
• MalfunctionApr 19, 2018Device Operates Differently Than Expected; Device Operates Differently Than Expected

  THE REPORTER INDICATED THAT PRIOR TO COMPLETE INSERTION OF A CC4204A, +18.0 DIOPTER, INTRAOCULAR LENS INTO THE PATIENT'S EYE IT WAS NOTED THAT THE TRAILING HAPTIC WAS TORN. THERE WAS NO PATIENT INJURY, NO ENLARGE INCISION TO REMOVE THE LENS. ANOTHER LENS WAS INSERTED TO COMPLETE PROCEDURE AND THE PATIENT WAS DISCHARGED WITHOUT FURTHER INCIDENT. CAUSE OF EVENT WAS UNKNOWN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7444738 ↗
• InjuryApr 4, 2018Device Operates Differently Than Expected; Device Dislodged or Dislocated; Device Operates Differently Than Expected; Device Dislodged or Dislocated

  THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A CC4204A,+18.0 DIOPTER, INTRAOCULAR LENS IN THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2018. IT WAS NOTICED THAT THE LENS "WOULD NOT CENTER", SO THE SURGEON REMOVED THE LENS ANS EXCHANGED IT FOR A 3 PIECE STAAR LENS. THE SURGEON USED A 2.75 BLADE FOR THE INITIAL INCISION, BUT HAD TO USE SUTURE TO CLOSE IT. NO OTHER DETAILS WERE PROVIDED.

  Patient problems: No Code Available

  MAUDE report 7398190 ↗

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