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

Model Number	VICM5 13.2
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/13/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A2 - 2000, a4 - unk, a5 - unk, a6 - unk, h6 - work order search: no similar complaint type events were reported for units within the same lot.Claim# (b)(4).
Event or Problem Description
The reporter indicated that a 13.2mm vicm5_13.2.-11.50 diopter implantable collamer lens lens tore/broke during injection/delivery into the eye.There was patient contact(lens touched the eye).No patient injury.The lens was exchanged with a same length lens.Additional information has been requested but none has been forthcoming.
Additional Manufacturer Narrative
The lens was exchanged with a same model and length lens on (b)(6) 2023.This resolved the problem.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 SURGICAL COMPANY; 1911 walker avenue; monrovia CA 91016
• Manufacturer Contact: joselene muniz ; 1911 walker avenue; monrovia, CA 91016
• MDR Report Key: 18258199
• Report Number: 2023826-2023-05319
• Device Sequence Number: 17132658
• Product Code: MTA
• UDI-Device Identifier: 00840311300969
• UDI-Public: 00840311300969
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: P030016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 02/20/2024

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: 05/31/2026
• Device Model Number: VICM5 13.2
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• 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: 11/17/2023
• Supplement Date Received by Manufacturer: 02/16/2024
• Initial Report FDA Received Date: 12/04/2023
• Supplement Report FDA Received Date: 02/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/11/2023
• 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#1639224; FOAMTIPPLUNGER MODEL#FTP,LOT#1648271
• Patient Sex: Female