Collamer Ultraviolet Absorbing Posterior Chamber Intraocular Lens CC4204A (UDI 00841542102421)Recalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 00841542102421), received between Jul 1, 2016 and Jul 22, 2020 — classified as 3 injuries, 19 malfunctions.

The most frequently reported specific device problem is “Device Operates Differently Than Expected” (9 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 22 most recent of 22 reports, in the reporter's own words as published by the FDA.

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

  A CC4204A COLLAMER SINGLE PIECE LENS, +21.5 DIOPTER, WAS RECEIVED BY THE MANUFACTURER DAMAGED. THERE WAS NO PATIENT CONTACT. A BACKUP LENS WAS IMPLANTED AND THE PROBLEM WAS RESOLVED. THE CAUSE OF THE EVENT WAS UNKNOWN.

  Patient problems: No Patient Involvement

  MAUDE report 10310695 ↗
• MalfunctionApr 14, 2020No Apparent Adverse Event; No Apparent Adverse Event

  A CC4204A INTRAOCULAR LENS DIOPTER +21.5 WAS RETURNED WITH NO REASON FOR THE RETURN INDICATED. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE NOT BEEN SUCCESSFUL.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9960154 ↗
• MalfunctionMar 9, 2020No Apparent Adverse Event; No Apparent Adverse Event

  A CC4204A, +21.5 DIOPTER, INTRAOCULAR LENS WAS RETURNED BACK TO US DAMAGE. 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 9806359 ↗
• InjuryDec 27, 2019No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTER INDICATED THE SURGEON INSERTED A CC4204A COLLAMER SINGLE PIECE LENS, +21.5 DIOPTER, AND THE LENS TORE. THE LENS WAS REMOVED WITH NO PATIENT INJURY. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NONE HAS BEEN FORTHCOMING. IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED.

  Patient problems: Clouding, Central Corneal; No Code Available; No Consequences Or Impact To Patient

  MAUDE report 9528025 ↗
• MalfunctionDec 4, 2019No Apparent Adverse Event; No Apparent Adverse Event

  A PIECE OF A CC4204A INTRAOCULAR LENS, DIOPTER +21.5 WAS RETURNED. ON THE BOX WAS WRITTEN, "TORE NOT IMPLANTED." ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE NOT BEEN SUCCESSFUL.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9412439 ↗
• MalfunctionMay 22, 2019No Apparent Adverse Event; No Apparent Adverse Event

  A PORTION OF CC4204A INTRAOCULAR LENS, DIOPTER +21.5 WAS RETURNED. "MISFIRE, PT CONTACT" WAS RECORDED ON THE BOX. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE NOT BEEN SUCCESSFUL.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8633165 ↗
• MalfunctionNov 12, 2018No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTER STATED THAT THERE WAS AN ISSUE WITH THE LOADING OF A CC4204A, +21.5 DIOPTER, INTRAOCULAR LENS AND WHEN THE SURGEON INSPECTED THE LENS IT WAS TORN IN TWO PIECES. THERE WAS NO PATIENT CONTACT AND THE BACKUP LENS WAS USED WITH NO ISSUES. CAUSE OF EVENT WAS REPORTED AS UNKNOWN.

  Patient problems: No Patient Involvement

  MAUDE report 8062523 ↗
• MalfunctionSep 13, 2018No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTER INDICATED THAT A CC4204A, +21.5 DIOPTER, INTRAOCULAR LENS HAD A BAD HAPTIC. IT WAS REPORTED THAT THERE WAS NO PATIENT INJURY. PATIENT CONTACT WAS REPORTED AS N/A. ANOTHER STAAR LENS SAME MODEL WAS IMPLANTED. REPORTER WAS UNABLE TO PROVIDE ADDITIONAL INFORMATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7874815 ↗
• MalfunctionSep 12, 2018No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTER INDICATED A CC4204A COLLAMER SINGLE PIECE LENS, +21.5 DIOPTER, WAS NOT INSERTED. 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 7871023 ↗
• MalfunctionMar 21, 2018Device Operates Differently Than Expected; Device Operates Differently Than Expected

  THE REPORTER INDICATED THAT THE SURGEON LOADED A CC4204A IMPLANTABLE COLLAMER LENS, +21.5 DIOPTER AND THE LENS TORE. THERE WAS NO PATIENT CONTACT. THE SURGEON DECIDED TO IMPLANT A NON STAAR LENS. THE REPORTER STATED THAT THE CAUSE OF EVENT WAS UNKNOWN.

  Patient problems: No Patient Involvement

  MAUDE report 7359984 ↗
• MalfunctionMar 21, 2018Device Operates Differently Than Expected; Device Operates Differently Than Expected

  THE REPORTER INDICATED THAT THE SURGEON INJECTED A CC4204A IMPLANTABLE COLLAMER LENS, +21.5 DIOPTER, IN THE PATIENT'S EYE AND A TEAR WAS NOTICED. THE LENS WAS REMOVED AND A NON STAAR LENS WAS IMPLANTED WITHIN THE SAME SURGERY. THERE WAS NO PATIENT INJURY. THE REPORTER STATED THAT THE CAUSE OF EVENT WAS UNKNOWN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7358667 ↗
• MalfunctionJan 30, 2018Device Operates Differently Than Expected; Device Operates Differently Than Expected

  THE REPORTER INDICATED THAT A (B)(4) COLLAMER SINGLE PIECE LENS, +21.5 DIOPTER, TORE DURING LOADING. THERE WAS NO PATIENT CONTACT. THE BACK UP LENS WAS IMPLANTED WITH NO PROBLEM. THE REPORTER STATED THAT THE CAUSE OF EVENT WAS UNKNOWN.

  Patient problems: No Patient Involvement

  MAUDE report 7229592 ↗
• MalfunctionJan 11, 2018Device Operates Differently Than Expected; Device Operates Differently Than Expected

  THE REPORTER INDICATED THAT A (B)(4) COLLAMER SINGLE PIECE LENS, +21.5 DIOPTER, HAD A SCRATCH. THERE WAS PATIENT CONTACT AND IT WAS A LOADING ISSUE. 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 7183213 ↗
• InjuryOct 5, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE REPORTER INDICATED THE SURGEON INSERTED AND REMOVED A CC4204A COLLAMER SINGLE PIECE LENS, +21.5 DIOPTER, DURING THE SAME SURGERY DUE TO WEAK ZONULE AND A THICKER LENS WAS REQUIRED. THE INCISION WAS ENLARGED TO REMOVE THE LENS AND SUTURES WERE REQUIRED TO CLOSE. THE REPORTER INDICATED THE CAUSE OF THE EVENT WAS DUE TO MINOR PRE-EXISTING CONDITION AND WAS PATIENT RELATED. THE REPORTER INDICATED THERE WAS NO ISSUE WITH THE PRODUCT. THE LENS WAS DISCARDED AT THE FACILITY.

  Patient problems: No Code Available

  MAUDE report 6917430 ↗
• MalfunctionSep 8, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  THE REPORTER INDICATED THE SURGEON LOADED A CC4204A COLLAMER SINGLE PIECE LENS, +21.5 DIOPTER, INTO THE CARTRIDGE AND THE LENS WAS DAMAGED AS IT WAS EXPRESSED IN ORDER TO BE RELOADED. THERE WAS NO PATIENT CONTACT OR INJURY. THE SURGEON CHANGED THE MODEL OF LENS IMPLANTED. THE REPORTER WAS UNABLE TO PROVIDE ANY ADDITIONAL INFORMATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6853791 ↗
• MalfunctionMay 30, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  THE REPORTER STATED THAT A CC4204A, +21.5 DIOPTER, SINGLE PIECE COLLAMER LENS TORE DURING INSERTION INTO THE EYE. THE DOCTOR HAD TO CUT THE LENS TO REMOVE IT. THERE WAS NO ENLARGEMENT OF THE INCISION. THE BACKUP LENS WAS IMPLANTED. NO SUTURES WERE USED AND THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6599785 ↗
• InjuryMay 26, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE REPORTER STATED THE SURGEON INSERTED A CC4204A COLLAMER SINGLE PIECE LENS, +21.5 DIOPTER, AND NOTED THE CAPSULE BAG HAD DISAPPEARED/COLLAPSED. THE INCISION WAS ENLARGED TO REMOVE THE LENS DURING THE SAME SURGERY AND AN ANTERIOR VITRECTOMY WAS PERFORMED. A 3 PIECE LENS (DIFFERENT MANUFACTURER) WAS IMPLANTED. A SUTURE WAS REQUIRED. THE REPORTER STATED THE CAUSE OF THE EVENT AND IF A CAPSULE TEAR HAD OCCURRED WAS UNKNOWN.

  Patient problems: No Code Available; Vitrectomy

  MAUDE report 6595982 ↗
• MalfunctionApr 5, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  THE REPORTER INDICATED A CC4204A COLLAMER SINGLE PIECE LENS, +21.5 DIOPTER, WAS REPORTED AS BEING DEFECTIVE. THERE WAS NO APPARENT PATIENT CONTACT OR INJURY. THE REPORTER INDICATED NO ADDITIONAL INFORMATION WAS AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6462591 ↗
• MalfunctionFeb 28, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  THE REPORTER STATED THAT THE SURGEON CHANGED FROM A CC4204A, +21.5 DIOPTER, IMPLANTABLE SINGLE PIECE COLLAMER LENS TO A DIFFERENT LENS DUE TO A BROKEN CAPSULE THAT OCCURRED PRIOR TO IMPLANTATION. THE REPORTER STATED THAT IT WAS NOT AN ISSUE WITH THE LENS. THERE WAS NO VITRECTOMY AND NO SUTURES NEEDED. 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 Consequences Or Impact To Patient

  MAUDE report 6366857 ↗
• MalfunctionOct 14, 2016Device Operates Differently Than Expected; Torn Material; Device Operates Differently Than Expected; Torn Material

  THE REPORTER INDICATED THE SURGEON IMPLANTED A CC4204A SINGLE-PIECE COLLAMER LENS, +21.5 DIOPTER, IN THE PATIENT'S EYE ON (B)(6) 2016. THE LENS WAS EXPLANTED ON (B)(6) 2016 DUE TO LENS TEAR DURING LOADING. THE REPORTER WAS UNABLE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE LENS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6031131 ↗
• MalfunctionAug 16, 2016Torn Material; Torn Material

  THE REPORTER STATED THE SURGEON INSERTED A CC4204A COLLAMER SINGLE PIECE LENS, +21.5 DIOPTER, AND THE LENS TORE. THE LENS WAS REMOVED WITH NO PATIENT INJURY AND WAS REPLACED WITH A THREE PIECE LENS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5880945 ↗
• MalfunctionJul 1, 2016Entrapment of Device; Entrapment of Device

  THE REPORTER STATED THE SURGEON WAS ADVANCING THE CC4204A COLLAMER SINGLE PIECE LENS +21.5 DIOPTER, WHEN THE HAPTIC WAS NOTED TO BE STUCK IN THE INJECTOR. THERE WAS NO PATIENT CONTACT WITH THE LENS OR INJECTOR. 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 Consequences Or Impact To Patient

  MAUDE report 5765341 ↗

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