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

Model Number VICM5_12.6

Device Problem No Apparent Adverse Event (3189)

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

Event Date 04/10/2024

Event Type  malfunction  

Event Description

The reporter indicated that the surgeon implanted a 12.6mm vicm5_12.6 implantable collamer lens of diopter -8.00 into the patients left eye (os) on (b)(6) 2024.Reportedly the lens got stuck in the cartridge/injection system.There was patient contact but no patient injury.The lens was implanted, removed and replaced intraoperatively with a backup lens.Additional information provided: "during lens insertion with the injector, the lens rotated about 10 degrees to 15 degrees within the eye.Since the front and back of the lens seemed to flip over within the anterior chamber, insertion was aborted and the lens was removed".The reporter indicated the cause of the event is unknown.

Manufacturer Narrative

H6- investigation type code: 4110- lens work order search-no similar complaint event(s) within associated lots were found.(b)(4).

Manufacturer Narrative

Corrected data: b5- the reporter indicated that the surgeon implanted a 12.6mm vicm5_12.6 implantable collamer lens of diopter -8.00 into the patients left eye (os) on (b)(6) 2024.Reportedly the lens got stuck in the cartridge/injection system.There was patient contact but no patient injury.The lens was implanted, removed and replaced intraoperatively with a backup lens and the problem was resolved.Additional information provided: "during lens insertion with the injector, the lens rotated about 10 degrees to 15 degrees within the eye.Since the front and back of the lens seemed to flip over within the anterior chamber, insertion was aborted and the lens was removed".The reporter indicated the cause of the event is unknown.Claim# (b)(4).

• Brand Name: IMPLANTABLE COLLAMER LENS (ICL)
• Type of Device: PHAKIC INTRAOCULAR LENS
• Manufacturer (Section D): STAAR SURGICAL COMPANY; 1911 walker avenue; monrovia CA 91016
• Manufacturer (Section G): STAAR SUGICAL COMPANY; 1911 walker avenue; monrovia CA 91016
• Manufacturer Contact: joselene muniz ; 1911 walker avenue; monrovia, CA 91016 ; 6263037902
• MDR Report Key: 19198938
• MDR Text Key: 341238566
• Report Number: 2023826-2024-01990
• Device Sequence Number: 1
• Product Code: MTA
• UDI-Device Identifier: 00840311300563
• UDI-Public: 00840311300563
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P030016
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/25/2024

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: VICM5_12.6
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/25/2024
• Initial Date FDA Received: 04/27/2024
• Supplement Dates Manufacturer Received: 04/29/2024
• Supplement Dates FDA Received: 04/30/2024
• Date Device Manufactured: 11/05/2023
• 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# 1660110; FOAM TIP PLUNGER (FTP), LOT# 1710803; MSI-PF, LOT# 1589919
• Patient Sex: Female