Collamer Ultraviolet Absorbing Posterior Chamber Intraocular Lens CC4204A (UDI 00841542102384)Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 00841542102384), received between Jul 16, 2016 and Jun 22, 2021 — classified as 1 injury, 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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 22, 2021No Apparent Adverse Event; No Apparent Adverse Event

  A CC240A +19.5 DIOPTER INTRAOCULAR LENS WAS RETURNED WITH THE NOTE "TORN LENS LOADING ERROR, LENS WAS OPENED BUT NOT USED, NO PATIENT CONTENT".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12044114 ↗
• MalfunctionApr 1, 2020No Apparent Adverse Event; No Apparent Adverse Event

  A CC4204A, +19.50 DIOPTER, INTRAOCULAR LENS WAS RETURNED BACK TO US DAMAGED. 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 9913769 ↗
• MalfunctionFeb 26, 2020Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  THE REPORTER INDICATED THAT A CC4204A, +19.50 DIOPTER, INTRAOCULAR LENS WOULD NOT UNFOLD ONCE IMPLANTED. THE LENS WAS REMOVED AND THE BACKUP LENS WAS IMPLANTED INTRAOPERATIVELY. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9759307 ↗
• 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, +19.5 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 WITH CORNEAL EDEMA."

  Patient problems: Corneal Edema; No Known Impact Or Consequence To Patient

  MAUDE report 9460055 ↗
• MalfunctionSep 5, 2019Contamination /Decontamination Problem; Contamination /Decontamination Problem

  A CC4204A INTRAOCULAR LENS, DIOPTER +19.5 WAS REQUESTED TO BE RETURNED. REPORTER STATES THAT DURING THE LOADING PROCESS IT WAS DISCOVERED THAT THE LENS HAS AN "UNREMOVABLE PARTICLE" ON IT. THERE WAS NO PATIENT CONTACT WITH THE LENS. THIS OCCURRED ON (B)(6) 2019.

  Patient problems: No Patient Involvement

  MAUDE report 8966523 ↗
• MalfunctionJul 25, 2019No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTER STATED THAT A CC4204A INTRAOCULAR LENS, DIOPTER +19.5, HAD NO PATIENT CONTACT, STUCK IN LOADER. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE NOT BEEN SUCCESSFUL.

  Patient problems: No Patient Involvement

  MAUDE report 8826768 ↗
• MalfunctionMay 9, 2019No Apparent Adverse Event; No Apparent Adverse Event

  A CC4204A INTRAOCULAR LENS, DIOPTER +19.5 WAS RETURNED DAMAGED, THOUGH "OPENED NOT USED" 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 8595425 ↗
• MalfunctionDec 13, 2018No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTER INDICATED THAT ON (B)(6) 2018 A CC4204A, +19.5 DIOPTER, INTRAOCULAR LENS TORE ON LOADING. THERE WERE NO PROBLEMS DURING LOADING, ADVANCEMENT OF THE LENS, OR UNUSUAL EVENTS THAT LED TO THE TEAR. IT WAS REPORTED THAT THERE WAS NO PATIENT CONTACT. THE BACK-UP LENS WAS IMPLANTED INTRAOPERATIVELY.

  Patient problems: No Patient Involvement

  MAUDE report 8159590 ↗
• MalfunctionOct 28, 2018No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTER INDICATED A CC4204A COLLAMER SINGLE PIECE LENS, +19.5 DIOPTER, COULD NOT BE LOADED AND THERE WAS NO PATIENT CONTACT. THE REPORTER INDICATED IT WAS UNKNOWN IF THE LENS WAS 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 Patient Involvement

  MAUDE report 8011759 ↗
• InjurySep 18, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE REPORTER INDICATED THAT, AS THE SURGEON WAS IMPLANTING A CC4204A INTRAOCULAR LENS, DIOPTER +19.5 INTO THE PATIENT'S LEFT (OS) EYE, HE NOTICED THAT THE INCISION WAS NOT LARGE ENOUGH. THE LENS WAS REMOVED IN ORDER TO ENLARGE THE INCISION AND HAD NOT BEEN FULLY IMPLANTED. THOUGH NO VISIBLE DAMAGE WAS NOTICEABLE ON THE LENS, THE SURGEON DECIDED TO IMPLANT AN ALTERNATE LENS. THE PROBLEM WAS RESOLVED. THIS OCCURRED ON (B)(6) 2018.

  Patient problems: No Code Available

  MAUDE report 7886306 ↗
• MalfunctionOct 16, 2017Entrapment of Device; Device Operates Differently Than Expected; Entrapment of Device; Device Operates Differently Than Expected

  THE REPORTER INDICATED THAT THE SURGEON ATTEMPTED TO IMPLANT A CC4204A, +19.5 DIOPTER, INTRAOCULAR LENS IN THE PATIENT'S EYE ON (B)(6) 2017. THE SURGEON NOTICED THAT THE LENS GOT STUCK AND DAMAGED IN THE INSERTER, PRIOR TO PATIENT CONTACT. A BACK UP LENS WAS THEN USED.

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

  MAUDE report 6952445 ↗
• MalfunctionOct 11, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  THE REPORTER INDICATED THAT, DURING AN ATTEMPT TO IMPLANT A (B)(4) IMPLANTABLE COLLAMER LENS DIOPTER +19.5 INTO THE PATIENT'S EYE, THE LENS RIPPED. THE LENS RIPPED DURING ADVANCEMENT PRIOR TO INSERTION. REPORTEDLY, THERE WAS NO PATIENT CONTACT WITH THE LENS. A BACK-UP LENS WAS IMPLANTED. ATTEMPTS TO OBTAIN ADDITIONAL DETAILS HAVE NOT BEEN SUCCESSFUL.

  Patient problems: No Patient Involvement

  MAUDE report 6941364 ↗
• MalfunctionOct 11, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  THE REPORTER INDICATED THAT DURING AN ATTEMPT TO IMPLANT A (B)(4) IMPLANTABLE COLLAMER LENS, DIOPTER +19.5 INTO THE PATIENT'S LEFT (OS) EYE, THE DOCTOR NOTICED THE LENS WAS TORN. THE LENS WAS PARTIALLY INSERTED INTO THE EYE AND REMOVED WITH NO PATIENT INJURY REPORTED. THE LENS WAS REPLACED WITH ANOTHER STAAR LENS. THIS OCCURRED ON (B)(6) 2017. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE NOT BEEN SUCCESSFUL.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6941362 ↗
• MalfunctionAug 2, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  THE REPORTER INDICATED THAT AS THE SURGEON WAS IMPLANTING A CC4204A IMPLANTABLE COLLAMER LENS, DIOPTER +19.5, INTO THE PATIENT'S EYE, THE LENS TORE. THE REPORTER STATED THAT NOTHING UNUSUAL OCCURRED DURING THE SURGERY AND AN EXPERIENCED TECHNICIAN PERFORMED THE PROCEDURE. THE LENS WAS EXCHANGED DURING THE SAME SURGERY. THE PROBLEM WAS RESOLVED. THIS OCCURRED ON (B)(6) 2017.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6762511 ↗
• MalfunctionMay 2, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  THE REPORTER INDICATED THAT BEFORE INSERTING A CC4204A COLLAMER SINGLE PIECE LENS, +19.5 DIOPTER, INTO THE EYE A TEAR WAS NOTICED. THERE WAS NO PATIENT CONTACT OR INJURY AND THE BACKUP LENS WAS IMPLANTED.

  Patient problems: No Patient Involvement

  MAUDE report 6539046 ↗
• MalfunctionMar 6, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  THE REPORTER STATED THAT A CC4204A, +19.5 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 6382929 ↗
• MalfunctionJul 16, 2016Torn Material; Torn Material

  THE CUSTOMER RETURNED A CC4204A COLLAMER SINGLE PIECE LENS, +19.5 DIOPTER, TO THE MANUFACTURER TORN. THERE WAS NO PATIENT CONTACT. 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 5800479 ↗

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