Collamer Ultraviolet Absorbing Posterior Chamber Intraocular Lens CC4204A (UDI 00841542102414)Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 00841542102414), received between May 11, 2016 and Sep 17, 2020 — classified as 2 injuries, 18 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 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 17, 2020No Apparent Adverse Event; No Apparent Adverse Event

  A CC4204A INTRAOCULAR LENS, DIOPTER +21.0 WAS RETURNED TO STAAR SURGICAL WITH THE WORDS, "MISLOAD. NO PT CONTACT" RECORDED ON THE BOX. THE LENS WAS RETURNED DAMAGED. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE NOT BEEN SUCCESSFUL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10551353 ↗
• MalfunctionJun 10, 2020No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTER STATES THAT A CC4204A INTRAOCULAR LENS, DIOPTER +21.0 RIPPED WAS OPENED BUT NOT USED; THE LENS WOULD NOT LOAD IN THE CARTRIDGE. THIS OCCURRED ON (B)(6) 2020. REPORTEDLY, NO ADDITIONAL INFORMATION IS AVAILABLE REGARDING THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10140607 ↗
• MalfunctionNov 13, 2019No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTER STATES THAT AS THE SURGEON ATTEMPTED TO IMPLANT A CC4204A INTRAOCULAR LENS, DIOPTER +21.0, IT DID NOT ADVANCE CORRECTLY. WHEN TRYING TO RELOAD THE LENS, IT RIPPED. THERE WAS NO PATIENT CONTACT WITH THE LENS. THIS OCCURRED ON (B)(6) 2019.

  Patient problems: No Patient Involvement

  MAUDE report 9317926 ↗
• MalfunctionMay 31, 2019No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTER INDICATED THAT A CC4204A, +21.0 DIOPTER, INTRAOCULAR LENS WAS DAMAGED BY THE DOCTOR. THERE WAS PATIENT CONTACT BUT NO PATIENT INJURY. THE BACKUP LENS WAS IMPLANTED AT THE SAME SURGERY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8658129 ↗
• InjuryJan 11, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE REPORTER INDICATED THAT A CC4204A, +21.0 DIOPTER, INTRAOCULAR LENS, RIPPED DURING IMPLANT. THE LENS WAS IMPLANTED, REMOVED AND REPLACED WITHIN THE SAME SURGERY. THE SURGEON ENLARGED AND SUTURE THE INCISION. PATIENT IS DOING WELL. CAUSE OF EVENT IS UNKNOWN. A STAAR DELIVERY SYSTEM WAS USED; MODEL AND LOT NUMBERS ARE NOT AVAILABLE. ANOTHER SAME MODEL LENS WAS IMPLANTED WITH NO PROBLEM. THE REPORTER WAS UNABLE TO PROVIDE ADDITIONAL INFORMATION.

  Patient problems: No Code Available

  MAUDE report 8241720 ↗
• MalfunctionSep 25, 2018No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTER INDICATED THAT THE SURGEON NOTICED A CC4204A, +21.0 DIOPTER, INTRAOCULAR LENS HAD A TEAR DURING INSERTION. IT WAS REPORTED THAT THERE WAS PATIENT CONTACT BUT NO PATIENT INJURY. THERE IS NO CERTAINTY TO THE CAUSE OF THE EVENT. BACKUP LENS WAS INSERTED WITHOUT ANY REPORTED PROBLEMS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7906094 ↗
• MalfunctionSep 6, 2018No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTER INDICATED THAT, AS THE SURGEON WAS LOADING A CC4204A INTRAOCULAR LENS, DIOPTER +21.0, INTO THE PATIENT'S RIGHT (OD) EYE, THE LENS WAS SCRATCHED. THE REPORTER IS UNSURE WHETHER THERE WAS PATIENT CONTACT WITH THE LENS. THIS OCCURRED ON (B)(6) 2018. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE NOT BEEN SUCCESSFUL.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7852998 ↗
• MalfunctionAug 28, 2018No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTER INDICATED OF A CC4204A, +21.0 DIOPTER, INTRAOCULAR LENS TO BE IRREGULAR. IT WAS REPORTED THAT THERE WAS PATIENT CONTACT BUT NO PAITENT INJURY. THE REPORTER WAS UNABLE TO PROVIDE ADDITIONAL INFORMATION ON THE EVENT.

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

  MAUDE report 7825098 ↗
• MalfunctionMar 14, 2018Device Operates Differently Than Expected; Device Operates Differently Than Expected

  THE REPORTER INDICATED THAT THE SURGEON WAS INSERTING A CC4204A COLLAMER SINGLE PIECE LENS, +21.0 DIOPTER, IN THE PATIENT'S LEFT EYE AND A TEAR WAS NOTICED. THERE WAS PATIENT CONTACT BUT NO PATIENT INJURY. THE BACKUP LENS WAS USED. THE REPORTER STATED THAT THE CAUSE OF EVENT IS "WHEN USING THE NANOPOINT".

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7339963 ↗
• MalfunctionMar 13, 2018Device Operates Differently Than Expected; Device Operates Differently Than Expected

  THE REPORTER INDICATED THAT THE SURGEON MADE AN INCISION IN THE PATIENT'S LEFT (OS) EYE IN ORDER TO IMPLANT A CC4204A INTRAOCULAR LENS, DIOPTER +21.0. REPORTEDLY, THE SURGEON PLACED THE INJECTOR INTO THE EYE AND WHEN HE ATTEMPTED TO INSERT THE LENS, THE LENS REMAINED STUCK IN THE INJECTOR. THE DEVICE WAS THEN REMOVED FROM THE EYE. DATE OF SURGERY WAS (B)(6) 2018.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7336767 ↗
• MalfunctionDec 12, 2017Device Operates Differently Than Expected; Mechanical Jam; Device Operates Differently Than Expected; Mechanical Jam

  THE REPORTER INDICATED THAT, AS THE SURGEON WAS LOADING A CC4204A INTRAOCULAR LENS, DIOPTER +21.0, IN PREPARATION TO IMPLANT INTO THE PATIENT'S EYE, THE LENS GOT STUCK IN THE INJECTOR. REPORTEDLY, THERE WAS NO PATIENT CONTACT WITH THE LENS. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE NOT BEEN SUCCESSFUL.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7109946 ↗
• MalfunctionNov 28, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  THE REPORTER INDICATED THE SCRUB TECHNICIAN ACCIDENTLY TORE A CC4204A COLLAMER SINGLE PIECE LENS, +21.0 DIOPTER, WHILE LOADING, BUT IT WAS NOT NOTICED UNTIL THE LENS WAS INSERTED AND WAS REMOVED IMMEDIATELY. THERE WAS NO PATIENT INJURY, NO ENLARGED INCISION OR SUTURES. ANOTHER LENS OF THE SAME MODEL AND DIOPTER WAS USED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7065508 ↗
• MalfunctionOct 5, 2017Entrapment of Device; Entrapment of Device

  THE REPORTER INDICATED THAT DURING AN ATTEMPT TO IMPLANT A CC4204A IMPLANTABLE COLLAMER LENS, DIOPTER +21.0 INTO THE PATIENT'S EYE, THE TECHNICIAN WAS UNABLE TO FULLY INSERT THE LENS. THE TECH WAS UNABLE TO ADVANCE THE LENS IN THE INJECTOR. THE LENS WAS PARTIALLY INSERTED. THE LENS WAS REMOVED AND EXCHANGED WITH THE BACK-UP LENS DURING THE SAME SURGERY WTH NO PATIENT EVENT OR INJURY. THE PROBLEM WAS RESOLVED. THIS OCCURRED ON (B)(6) 2017.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6918314 ↗
• MalfunctionJun 2, 2017Mechanical Jam; Mechanical Jam

  THE REPORTER STATED THAT A CC4204A, +21.0 DIOPTER, COLLAMER SINGLE PIECE INTRAOCULAR LENS GOT STUCK IN THE CARTRIDGE AND WAS NOT USED. THERE WAS NO PATIENT CONTACT. THE REPORTER WAS UNABLE TO PROVIDE FURTHER INFORMATION.

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 6609865 ↗
• MalfunctionMar 23, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  THE REPORTER STATED THAT BEFORE LOADING A CC4204A COLLAMER SINGLE PIECE LENS, +21.0 DIOPTER, THE DOCTOR NOTICED THE LENS WAS DAMAGED. THERE WAS NO PATIENT CONTACT AND ANOTHER LENS SAME MODEL WAS IMPLANTED. THE REPORTER STATED THAT THE CAUSE OF THE EVENT WAS UNKNOWN.

  Patient problems: No Patient Involvement

  MAUDE report 6430459 ↗
• MalfunctionMar 6, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  THE REPORTER STATED THAT A CC4204A, +21.0 DIOPTER, IMPLANTABLE COLLAMER LENS WAS OPENED BUT NOT USED. THERE WAS NO PATIENT CONTACT. THE REPORTER WAS UNABLE TO PROVIDE FURTHER INFORMATION ON THE DAMAGED LENS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6380686 ↗
• MalfunctionJul 19, 2016Entrapment of Device; Entrapment of Device

  THE CC4204A COLLAMER SINGLE PIECE LENS +21.0 DIOPTER WAS RETURNED TO THE MANUFACTURER STUCK INSIDE THE NANOPOINT CARTRIDGE. 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 5806559 ↗
• MalfunctionJul 1, 2016Torn Material; Torn Material

  THE REPORTER STATED THE SURGEON INSERTED A CC4204A COLLAMER SINGLE PIECE LENS, +21.0 DIOPTER, AND THE LENS TORE. THE LENS WAS REMOVED WITH NO PATIENT INJURY AND THE BACKUP LENS WAS IMPLANTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5766341 ↗
• InjuryMay 17, 2016Torn Material; Torn Material

  THE REPORTER INDICATED THE SURGEON IMPLANTED A CC4204A +21.00 DIOPTER COLLAMER SINGLE PIECE LENS IN THE PATIENT'S LEFT EYE. THE LENS TORE ON INSERTION INTO THE EYE. THERE WAS A CAPSULE TEAR AND A VITRECTOMY WAS PERFORMED. THE LENS WAS REMOVED AND A 3-PIECE STAAR LENS WAS IMPLANTED. CAUSE OF LENS TEAR AND CAPSULE TEAR IS UNKNOWN.

  Patient problems: Capsular Bag Tear; Vitrectomy

  MAUDE report 5661777 ↗
• MalfunctionMay 11, 2016Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  THE REPORTER INDICATED THE SURGEON IMPLANTED A CC4204A +21.00 DIOPTER COLLAMER SINGLE PIECE LENS IN THE PATIENT'S LEFT EYE. ONCE THE LENS WAS IMPLANTED, THE PHYSICIAN NOTICED IT WAS TOO TIGHT. THE LENS WAS TOO BIG. THE LENS WAS CUT INTO PIECES TO REMOVE FROM EYE. THE PHYSICIAN DECIDED TO IMPLANT A CQ2015A LENS. NO PATIENT INJURY. CAUSE OF THIS INCIDENT IS UNKNOWN. THE REPORTER WAS ASKED IF THE CAUSE WAS DUE TO MIS-MEASUREMENT OR DUE TO PATIENT ANATOMY AND THEY SAID NO, IT WAS JUST NOT A RIGHT FIT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5648957 ↗

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