Collamer Ultraviolet Absorbing Posterior Chamber Intraocular Lens CC4204A (UDI 00841542102339)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00841542102339), received between Feb 13, 2017 and Sep 3, 2019 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Device Operates Differently Than Expected” (2 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjurySep 3, 2019No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTER INDICATED THAT THE SURGEON NOTICED A CC4204A, +17.0 DIOPTER, INTRAOCULAR LENS HAD A TEAR DURING INSERTION. IT WAS REPORTED THAT THERE WAS PATIENT CONTACT BUT NO PATIENT INJURY. THE INCISION WAS SLIGHTLY ENLARGED TO REMOVE AND EXCHANGE LENS DURING THE INITIAL SURGERY. PER THE REPORTER ON (B)(6) 2019, "THIS WAS A LOADING ISSUE AND NOT A LENS ISSUE."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8957659 ↗
• MalfunctionSep 8, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  THE REPORTER INDICATED THE SURGEON ATTEMPTED TO INSERT A CC4204A COLLAMER SINGLE PIECE LENS, +17.0 DIOPTER, BUT NOTED THE LENS WAS TORN. THE LENS WAS PARTIALLY INSERTED INTO THE EYE AND WAS REMOVED WITH NO PATIENT INJURY. THE BACKUP LENS WAS IMPLANTED WITH NO PROBLEM. THE REPORTER STATED THE LENS WAS MOST LIKELY TORN DURING LOADING BUT THE CAUSE WAS UNKNOWN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6853788 ↗
• MalfunctionFeb 13, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  A CC4204A, COLLAMER SINGLE PIECE INTRAOCULAR LENS, +17.0 DIOPTER WAS RETURNED TO THE MANUFACTURER WITH THE LENS HAPTIC TORN. THE REPORTER STATED THAT THE BACK UP LENS WAS IMPLANTED DURING THE INITIAL SURGERY BUT 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 6327133 ↗

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