Collamer Ultraviolet Absorbing Posterior Chamber Intraocular Lens CC4204A (UDI 00841542102445)Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 00841542102445), received between Dec 15, 2016 and Jan 28, 2020 — classified as 2 injuries, 16 malfunctions.

The most frequently reported specific device problem is “Device Operates Differently Than Expected” (6 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 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 28, 2020No Apparent Adverse Event; No Apparent Adverse Event

  A CC4204A INTRAOCULAR LENS DIOPTER +22.5 WAS RETURNED WITH THE WORDS "NO PATIENT CONTACT" WRITTEN ON THE OUTER BOX. THE LENS WAS EXPIRED AND HAD A TEAR ON THE HAPTIC. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE NOT BEEN SUCCESSFUL.

  Patient problems: No Patient Involvement

  MAUDE report 9639150 ↗
• MalfunctionDec 12, 2019Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A CC4204A, +22.5 DIOPTER, INTRAOCULAR LENS FROM PATIENT'S EYE ON (B)(6) 2019. SURGEON "FELT" THE LENS DID NOT FIT IN THE EYE. THERE WAS NO PATIENT INJURY. THE LENS IMPLANTED, REMOVED, AND REPLACED INTRAOPERATIVELY. THIS RESOLVED THE PROBLEM. REPORTEDLY THE LENS WAS "REPLACED WITH ANOTHER STAAR LENS." PER REPORTER ON (B)(6) 2019, "PATIENT IS HEALING WELL."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9460059 ↗
• MalfunctionDec 5, 2019No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTER INDICATED THAT A C4204A, +22.5 DIOPTER, INTRAOCULAR LENS "WAS LOADED INCORRECTLY, INSERTED AND REMOVED." 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 9416951 ↗
• InjuryNov 13, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE REPORTER INDICATED THAT CC4204A, +22.50 DIOPTER, INTRAOCULAR LENS WAS IMPLANTED AND REMOVED, THERE WAS A CAPSULAR TEAR. ANOTHER LENS WAS IMPLANTED WITH NO PATIENT INJURY. 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 Code Available

  MAUDE report 9316077 ↗
• MalfunctionSep 16, 2019No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTER INDICATED THAT A CC4204A, +22.5 DIOPTER, INTRAOCULAR LENS WAS IMPLANTED, REMOVED AND REPLACED DUE TO THE LENS TEARING DURING LOADING. THERE WAS NO PATIENT INJURY. CAUSE OF EVENT WAS UNKNOWN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9070586 ↗
• InjuryAug 14, 2019Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  THE REPORTER INDICATED A CC4204A COLLAMER SINGLE PIECE LENS, +22.5 DIOPTER, TORE INJECTING OUT OF THE CARTRIDGE, WHILE BEING INSERTED. THE INCISION WAS ENLARGED TO REMOVE THE LENS FROM THE PATIENTS EYE. ANOTHER SAME MODEL AND DIOPTER LENS WAS IMPLANTED AND THE PROBLEM WAS RESOLVED. SUTURES WERE NOT REQUIRED. THE REPORTER INDICATED THE CAUSE OF THE EVENT WAS DUE TO USER ERROR, THE LENS WAS LOADED INCORRECTLY. THE REPORTER WAS UNABLE TO PROVIDE ANY ADDITIONAL INFORMATION.

  Patient problems: No Code Available

  MAUDE report 8895279 ↗
• MalfunctionJul 16, 2019No Apparent Adverse Event; No Apparent Adverse Event

  A CC4204A INTRAOCULAR LENS, DIOPTER +22.5 WAS REQUESTED TO BE RETURNED. REPORTER STATES THE LENS HAS A BENT HAPTIC AND THERE WAS NO PATIENT CONTACT WITH THE LENS. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE NOT BEEN SUCCESSFUL.

  Patient problems: No Patient Involvement

  MAUDE report 8795452 ↗
• MalfunctionMar 21, 2019No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTER INDICATED THAT A CC4204A, +22.5 DIOPTER, INTRAOCULAR LENS WAS IMPLANTED AND REMOVED DUE TO LENS TEARING. 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 Code Available; No Consequences Or Impact To Patient

  MAUDE report 8440306 ↗
• MalfunctionMar 20, 2019No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTER INDICATED A CC4204A COLLAMER SINGLE PIECE LENS, +22.5 DIOPTER, CRUMPLED AND THERE WAS NO PATIENT CONTACT. THE REPORTER INDICATED THEY HAVE SOME NEW NURSES THAT ARE LEARNING THE SYSTEM. THE REPORTER WAS UNABLE TO PROVIDE ANY ADDITIONAL INFORMATION.

  Patient problems: No Patient Involvement

  MAUDE report 8438560 ↗
• MalfunctionMar 19, 2019No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTER INDICATED A CC4204A COLLAMER SINGLE PIECE LENS, +22.5 DIOPTER, CRUMPLED AND THERE WAS NO PATIENT CONTACT. THE REPORTER INDICATED THEY HAVE SOME NEW NURSES THAT ARE LEARNING THE SYSTEM. THE REPORTER WAS UNABLE TO PROVIDE ANY ADDITIONAL INFORMATION.

  Patient problems: No Patient Involvement

  MAUDE report 8434595 ↗
• MalfunctionMay 22, 2018Device Operates Differently Than Expected; Device Operates Differently Than Expected

  THE REPORTED INDICATED THAT A CC4204A, +22.5 DIOPTER, INTRAOCULAR LENS TORE DURING LOADING. THERE WAS NO PATIENT CONTACT OR INJURY AND THE BACKUP LENS WAS IMPLANTED. THE REPORTED STATED THAT THE CAUSE OF THE EVENT WAS THE INJECTOR.

  Patient problems: No Patient Involvement

  MAUDE report 7534981 ↗
• MalfunctionMay 18, 2018Device Operates Differently Than Expected; Device Operates Differently Than Expected

  THE REPORTER INDICATED THE SURGEON WAS INSERTING A CC4204A COLLAMER SINGLE PIECE LENS, +22.5 DIOPTER AND NOTED THE LENS WAS TORN. THERE WAS PATIENT CONTACT BUT NO INJURY. THE BACKUP LENS WAS IMPLANTED. THE REPORTER INDICATED THE SURGEON STATED THE LENS WAS LOADED INCORRECTLY AND WAS DUE TO A LOADING ERROR.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7527867 ↗
• MalfunctionMar 14, 2018Mechanical Jam; Mechanical Jam

  THE REPORTED INDICATED THAT THE SURGEON LOADED A CC4204A INTRAOCULAR LENS, +22.5 DIOPTER AND THE LENS GOT STUCK IN THE CARTRIDGE. THERE WAS NO PATIENT CONTACT AND THE BACK UP LENS WAS USED. THE REPORTER STATED THAT THE CAUSE OF EVENT WAS UNKNOWN.

  Patient problems: No Patient Involvement

  MAUDE report 7339848 ↗
• MalfunctionSep 11, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  THE REPORTER INDICATED THAT THE SURGEON NOTICED THAT THE CC4204A, +22.5 DIOPTER, INTRAOCULAR LENS TORE WHILE IT WAS BEING LOADED ON (B)(6) 2017. THERE WAS NOT PATIENT CONTACT WITH THE TORN LENS. A BACK-UP LENS, SAME SIZE AND SAME DIOPTER, WAS USED AND IT WAS SUCCESSFUL.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 6856350 ↗
• MalfunctionMay 31, 2017Patient-Device Incompatibility; Patient-Device Incompatibility

  THE REPORTER STATED THAT A CC4204A COLLAMER SINGLE PIECE LENS, +22.5 DIOPTER, WAS IMPLANTED AND REMOVED WITHIN THE SAME SURGERY BECAUSE THE DOCTOR HAD TO GO WITH A THREE PIECE LENS DUE TO PATIENTS ANATOMY. THERE WAS NO PATIENT INJURY OR ADVERSE EVENTS. REPORTER STATED THAT THE CAUSE OF THE EVENT WAS NOT PRODUCT RELATED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6601457 ↗
• MalfunctionMay 25, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  THE REPORTER STATED THAT A CC4204A COLLAMER SINGLE PIECE LENS, +22.5 DIOPTER, KEPT GOING INTO THE POSTERIOR CHAMBER. THE LENS WAS REMOVED AND THE SURGEON DECIDED TO GO WITH A ANTERIOR LENS. THERE WAS NO ADVERSE EVENT OR PATIENT INJURY. THE REPORTER STATED THAT THE CAUSE OF THE EVENT IS UNKNOWN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6591562 ↗
• MalfunctionFeb 13, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  THE REPORTER STATED THAT A (B)(4), COLLAMER SINGLE PIECE INTRAOCULAR LENS, +22.5 DIOPTER WAS TORN AND THERE WAS PATIENT CONTACT. THE REPORTER WAS UNABLE TO PROVIDE FURTHER INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6326999 ↗
• MalfunctionDec 15, 2016Device Operates Differently Than Expected; Device Operates Differently Than Expected

  THE MANUFACTURER RECEIVED A DAMAGED CC4204A COLLAMER SINGLE PIECE LENS, +22.5 DIOPTER. 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 6176016 ↗

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