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

Model Number	VICM5_12.6
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/10/2024
Type of Reportable Event	Malfunction
Event or Problem 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.
Additional Manufacturer Narrative
H6- investigation type code: 4110- lens work order search-no similar complaint event(s) within associated lots were found.(b)(4).
Additional 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)
• Common Device Name: 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
• Report Number: 2023826-2024-01990
• Device Sequence Number: 12852111
• Product Code: MTA
• UDI-Device Identifier: 00840311300563
• UDI-Public: 00840311300563
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P030016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2026
• Device Model Number: VICM5_12.6
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/25/2024
• Supplement Date Received by Manufacturer: 04/29/2024
• Initial Report FDA Received Date: 04/27/2024
• Supplement Report FDA Received Date: 04/30/2024
• Date Device Manufactured: 11/05/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CARTRIDGE MODEL: SFC-45: LOT# 1660110; FOAM TIP PLUNGER (FTP), LOT# 1710803; MSI-PF, LOT# 1589919
• Patient Sex: Female