Collamer Ultraviolet Absorbing Posterior Chamber Intraocular Lens CC4204A (UDI 00841542102407)Recalls & reported problems

Summary

The FDA's MAUDE database contains 25 adverse event reports that list this exact device (DI 00841542102407), received between Sep 7, 2016 and Mar 31, 2021 — classified as 7 injuries, 18 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 25 most recent of 25 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 31, 2021No Apparent Adverse Event; No Apparent Adverse Event

  A CC4204A, +20.5 DIOPTER, INTRAOCULAR LENS WAS RETURNED DAMAGED. NOTE ON PACKAGING BOX INDICATED " LOADING ERROR, NO PATIENT CONTACT." IF ADDITIONAL INFORMATION IS RECEIVED A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11600401 ↗
• MalfunctionDec 31, 2020No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTER INDICATED THAT A CC4202A, +20.5 DIOPTER, INTRAOCULAR LENS WAS MISLOADED IN CARTRIDGE AND HAPTIC TORE. THE REPORTER STATED "PLUNGER OVERRIDE OF IOL RESULTING IN TEARING OF IOL". NO PATIENT CONTACT OR INJURY. BACKUP LENS IMPLANTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11103405 ↗
• MalfunctionJun 3, 2020No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTER INDICATED THAT A CC4204A +20.5 DIOPTER, IMPLANTABLE COLLAMER LENS TORE BEFORE/DURING LOADING. THERE WAS PATIENT CONTACT. 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 Consequences Or Impact To Patient

  MAUDE report 10114932 ↗
• MalfunctionMar 30, 2020No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTER INDICATED THAT A CC4204A +20.5 DIOPTER, INTRAOCULAR LENS WAS DIFFICULT TO LOAD. THE SURGEON NOTED A TEAR IN THE LENS WHEN HE PLACED IT INTO THE PATIENTS EYE. THE LENS WAS REMOVED IMMEDIATELY AND REPLACED WITH THE BACKUP LENS, NO PATIENT INJURY WAS REPORTED. CAUSE OF EVENT IS UNKNOWN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9901239 ↗
• InjuryDec 12, 2019Application Program Problem: Parameter Calculation Error; Adverse Event Without Identified Device or Use Problem; Application Program Problem: Parameter Calculation Error; Adverse Event Without Identified Device or Use Problem

  THE REPORTER INDICATED THAT A CC4204A, +20.5 DIOPTER, INTRAOCULAR LENS WAS IMPLANTED INTO PATIENT'S EYE ON (B)(6) 2019. THE LENS WAS REMOVED AND REPLACED FOR A SMALLER DIOPTER LENS DUE TO "INCORRECT POWER CALCULATION" ON (B)(6) 2019. THIS RESOLVED THE PROBLEM. PER THE REPORTER ON (B)(6) 2019, "PATIENT IS HEALING WELL."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9460084 ↗
• MalfunctionDec 5, 2019No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTER INDICATED THAT THE HAPTIC OF A CC4204A, +20.5 DIOPTER, INTRAOCULAR LENS HAD A TEAR. 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 9416955 ↗
• InjuryOct 31, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE REPORTER INDICATED THAT THE INCISION WAS NOTED TO BE TOO SMALL FOR THE +20.5 LENS, CC4204A +20.5 DIOPTER, INTRAOCULAR LENS TO BE INJECTED. THE SURGEON TRIED PULLING THE LENS OUT, THE LENS RIPPED. A NEW LENS WAS OBTAINED AND IMPLANTED WITHOUT PROBLEMS. THIS WAS ALL DURING THE SAME SURGERY AND PATIENT DID NOT HAVE ANY ADVERSE EFFECTS FROM SURGERY. ENLARGEMENT OF INCISION WAS REPORTED.

  Patient problems: No Code Available

  MAUDE report 8025882 ↗
• MalfunctionOct 3, 2018No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTER INDICATED THAT A CC4204A,+20.5 DIOPTER, INTRAOCULAR LENS TORE DURING DELIVERY INTO THE EYE. THE LENS WAS REMOVED AND A BACK UP LENS WAS IMPLANTED WITHIN THE SAME SURGERY. THERE WAS NO PATIENT INJURY. THE REPORTER STATED THAT THE CAUSE OF THE EVENT WAS A LOADING ISSUE, LENS GOT CAUGHT IN THE INJECTOR.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7930909 ↗
• MalfunctionSep 18, 2018No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A CC4204A INTRAOCULAR LENS, DIOPTER +20.5 INTO THE PATIENT'S LEFT (OS) EYE. AFTER IMPLANT, HE DID NOT LIKE THE WAY THE LENS LOOKED IN THE EYE. INTRAOPERATIVELY, HE EXCHANGED THE LENS FOR A BACK-UP LENS. REPORTEDLY, NO PATIENT INJURY OCCURRED. THE PROBLEM WAS RESOLVED. THIS OCCURRED ON (B)(6) 2018.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7886298 ↗
• MalfunctionSep 13, 2018No Apparent Adverse Event; No Apparent Adverse Event

  A CC4204A INTRAOCULAR LENS, DIOPTER +20.5 WAS RETURNED WITH TEARS ON THE LENS. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE NOT BEEN SUCCESSFUL.

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

  MAUDE report 7873516 ↗
• MalfunctionSep 7, 2018No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTER INDICATED THAT A CC4204A, +20.5 DIOPTER, INTRAOCULAR LENS TORE DURING INSERTION. THERE WAS NO PATIENT INJURY AND THE BACKUP LENS WAS IMPLANTED WITH NO ISSUES. CAUSE OF EVENT WAS UNKNOWN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7857795 ↗
• InjuryAug 9, 2018Adverse 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 +20.5 DIOPTER, INTRAOCULAR LENS TORE ON INSERTION. THERE WAS NO ENLARGEMENT OF INCISION OR SUTURES AS PART OF THE LENS REMOVAL PROCESS. IT WAS REPORTED THAT A VITRECTOMY WAS PERFORMED AND A CQ2015 +20.5 DIOPTER, THREE PIECE INTRACULAR LENS WAS IMPLANTED INTRAOPERATIVELY. IT WAS REPORTED THAT A STAAR INJECTION SYSTEM WAS USED BUT MODEL AND LOT NUMBERS ARE UNKNOWN.

  Patient problems: Vitrectomy

  MAUDE report 7770017 ↗
• MalfunctionMay 22, 2018Device Operates Differently Than Expected; Device Operates Differently Than Expected

  THE REPORTED INDICATED THAT A CC4204A, +20.5 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 7534960 ↗
• MalfunctionJan 22, 2018Device Operates Differently Than Expected; Device Operates Differently Than Expected

  THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A CC4204A, +20.5 DIOPTER, INTRAOCULAR LENS IN THE PATIENT'S EYE ON (B)(6) 2017. IT WAS NOTICED THAT THE LENS TORE DURING INJECTION. THE LENS WAS INTRAOPERATIVELY EXPLANTED AND EXCHANGED WITH A SIMILAR LENS AND THE PATIENT IS CURRENTLY FINE. DURING EXPLANTATION; THE LENS HAD TO BE CUT OUT. THERE WAS NO PATIENT INJURY. THE SURGEON DOES NOT KNOW WHAT MAY HAVE CAUSE THE LENS TO TEAR.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7211133 ↗
• InjuryDec 14, 2017Scratched Material; Scratched Material

  THE REPORTER INDICATED THAT THE SURGEON IMPLANTED AND REMOVED A CC4204A, +20.5 DIOPTER, IMPLANTABLE COLLAMER LENS BECAUSE THE INCISION WAS NOT BIG ENOUGH AND THE LENS WAS SCRATCHED DURING INJECTION. THE REPORTER STATED THAT THE SCRATCH WAS NOTICED AFTER IMPLANTATION BUT THAT THE LENS COULD HAVE BEEN SCRATCHED AND JUST NOT NOTICED. THE LENS WAS REMOVED WITHIN THE SAME SURGERY AND THE BACK-UP LENS WAS IMPLANTED. THE INCISION WAS ENLARGED TO REMOVE THE LENS, NO SUTURE NEEDED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Code Available

  MAUDE report 7119107 ↗
• InjuryNov 1, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  THE REPORTER INDICATED THAT, AS THE SURGEON IMPLANTED A CC4204A IMPLANTABLE COLLAMER LENS, DIOPTER +20.5 INTO THE PATIENT'S EYE, HE NOTICED THE LENS WAS TORN AND "IT WOULD NOT RELEASE." THE LENS WAS NOT FULLY IMPLANTED, BUT DID TOUCH THE PATIENT'S EYE. THE LENS WAS EXCHANGED WITH A BACK-UP LENS, WITH NO PATIENT INJURY. THIS OCCURRED ON (B)(6) 2017.

  Patient problems: No Code Available; No Known Impact Or Consequence To Patient

  MAUDE report 6993875 ↗
• MalfunctionJun 29, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED A CC4204A COLLAMER SINGLE PIECE LENS, +20.5 DIOPTER, WAS IMPLANT/EXPLANT. 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 6679074 ↗
• MalfunctionMay 24, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  THE REPORTER STATED THAT A CC4204A, +20.0 DIOPTER, IMPLANTABLE COLLAMER LENS HAPTIC WAS BROKEN DURING LOADING. THERE WAS NO PATIENT CONTACT. THE REPORTER DID NOT KNOW IF THE BROKEN HAPTIC WAS CAUSED BY USER ERROR.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6588384 ↗
• MalfunctionApr 6, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  THE REPORTER STATED THE SURGEON INSERTED A CC4204A COLLAMER SINGLE PIECE LENS, +20.5 DIOPTER, AND THE TRAILING HAPTIC TORE. THE LENS WAS REMOVED WITHIN THE SAME SURGERY WITH NO PATIENT INJURY, NO INCISION ENLARGEMENT OR SUTURES. ANOTHER SAME MODEL/DIOPTER LENS WAS IMPLANTED WITH NO PROBLEM. THE REPORTER STATED THE CAUSE OF THE EVENT WAS UNKNOWN.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6468344 ↗
• InjuryFeb 9, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  A CC4204A, COLLAMER SINGLE PIECE INTRAOCULAR LENS, +20.5 DIOPTER WAS RETURNED TO THE MANUFACTURER TORN IN HALF. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NONE HAS BEEN FORTHCOMING. IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED.

  Patient problems: Capsular Bag Tear; No Known Impact Or Consequence To Patient; Vitrectomy

  MAUDE report 6315880 ↗
• MalfunctionDec 15, 2016Device Operates Differently Than Expected; Device Operates Differently Than Expected

  THE REPORTER STATED THE SURGEON WAS ATTEMPTING TO INSERT A CC4204A COLLAMER SINGLE PIECE LENS, +20.5 DIOPTER, AND NOTED THE LENS WAS TORN. THERE WAS NO PATIENT CONTACT AND THE BACKUP LENS WAS IMPLANTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6176020 ↗
• InjuryDec 15, 2016Scratched Material; Scratched Material

  THE REPORTER STATED THE SURGEON INSERTED A CC4204A COLLAMER SINGLE PIECE LENS, +20.5 DIOPTER, AND NOTED A SCRATCH ON THE LENS. THE INCISION WAS ENLARGED SLIGHTLY TO REMOVE THE LENS WITHIN THE SAME SURGERY AND THE BACKUP LENS WAS IMPLANTED. THE LENS WAS ALSO CUT TO REMOVE FROM THE EYE. THE REPORTER STATED IT WAS UNKNOWN IF SUTURES WERE REQUIRED. THE REPORTER STATED THE MOST LIKELY CAUSE OF THE EVENT WAS DUE TO A LOADING ERROR.

  Patient problems: No Code Available

  MAUDE report 6176009 ↗
• MalfunctionNov 9, 2016Torn Material; Torn Material

  THE REPORTER STATED THE SURGEON INSERTED A CC4204A COLLAMER SINGLE PIECE LENS, +20.5 DIOPTER, AND THE LENS TORE. THE LENS WAS PARTIALLY INSERTED AND WAS REMOVED WITHIN THE SAME SURGERY, WITH NO PATIENT INJURY. THE BACKUP LENS WAS IMPLANTED. THE REPORTER STATED THE LENS WAS NOT FOLDED PROPERLY DURING THE LOADING PROCESS AND THE CAUSE OF THE EVENT WAS DUE TO USER/TECHNIQUE ERROR.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6089923 ↗
• MalfunctionOct 14, 2016Torn Material; Torn Material

  THE REPORTER INDICATED THE SURGEON ATTEMPTED TO IMPLANT A CC4204A SINGLE-PIECE COLLAMER LENS, +20.5 DIOPTER, IN THE PATIENT'S EYE ON (B)(6) 2016. THE LENS WAS LOADED INTO THE INJECTOR AND TORE. NO PATIENT CONTACT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6031132 ↗
• MalfunctionSep 7, 2016Entrapment of Device; Entrapment of Device

  AN CC4204A COLLAMER SINGLE PIECE LENS +20.5 DIOPTER WAS RETURNED TO THE MANUFACTURER STUCK INSIDE THE NANOPOINT CARTRIDGE. THE REPORTER INDICATED THE LENS WAS NOT IMPLANTED AND THEY HAD NO ADDITIONAL INFORMATION TO PROVIDE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5934402 ↗

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