MAUDE Adverse Event Report: STAAR SURGICAL COMPANY IMPLANTABLE COLLAMER LENS (ICL); PHAKIC TORIC INTRAOCULAR LENS

Model Number VTICMO12.6

Device Problems Difficult to Fold, Unfold or Collapse (1254); Unintended Movement (3026)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/15/2021

Event Type  malfunction  

Manufacturer Narrative

This product is manufactured in the u.S.But not marketed in the u.S.No similar complaint was reported for units within the same lot.Claim # (b)(4).

Event Description

The reporter indicated the surgeon inserted and removed a 12.6mm vticmo12.6 implantable collamer lens, -13.00/+1.5/109 (sphere/ cylinder/ axis), within the same surgery due to the lens remained in the folded position (would not unfold) when delivered into the patients right eye (od).The lens was inserted again during the same surgery and again remained in the folded position.The surgeon managed to open the lens but it went into the eye upside down.The lens was removed with no patient injury.The surgeon did not implant another lens.The cause of the event was unknown.Additional information has been requested but none has been forthcoming.

Manufacturer Narrative

B5 - "the surgery was rearranged for (b)(6) however had to be cancelled again due to surgeon illness.Subsequently the patient decided against further surgery." should be added to the initial mdr.Claim #: (b)(4).

• Brand Name: IMPLANTABLE COLLAMER LENS (ICL)
• Type of Device: PHAKIC TORIC INTRAOCULAR LENS
• Manufacturer (Section D): STAAR SURGICAL COMPANY; 1911 walker avenue; monrovia CA 91016
• Manufacturer (Section G): STAAR SURGICAL COMPANY; 1911 walker avenue; monrovia CA 91016
• Manufacturer Contact: cynthia thai ; 1911 walker avenue; monrovia, CA 91016 ; 6263037902
• MDR Report Key: 13255769
• MDR Text Key: 286516626
• Report Number: 2023826-2022-00071
• Device Sequence Number: 1
• Product Code: QCB
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: VTICMO12.6
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/16/2021
• Initial Date FDA Received: 01/13/2022
• Supplement Dates Manufacturer Received: 04/11/2022
• Supplement Dates FDA Received: 04/11/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/01/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: CARTRIDGE MODEL SFC-45 - LOT # UNK.; FOAM TIP PLUNGER MODEL FTP - LOT # UNK.; INJECTOR MODEL MSI-PF - LOT # UNK.
• Patient Age: 25 YR
• Patient Sex: Female