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	08/02/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The reporter indicated that a 12.6mm vicm5 12.6, -11.00 diopter, implantable collamer lens was implanted, removed, and replaced with a same length lens intraoperatively on (b)(6) 2023 from patient's right eye (od) due to lens tear/break during loadingt.This resolved the problem.
Additional Manufacturer Narrative
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).

• 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: 17862039
• Report Number: 2023826-2023-04073
• Device Sequence Number: 20259966
• Product Code: MTA
• UDI-Device Identifier: 00840311300624
• UDI-Public: 00840311300624
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: P030016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/14/2023

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: 11/30/2025
• Device Model Number: VICM5 12.6
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/28/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/14/2023
• Initial Report FDA Received Date: 10/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/30/2022
• 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#1595379.; FOAMTIPPLUNGER MODEL#FTP,LOT#1643239.; INJECTOR MODEL#MSI-PF,LOT#UNK.
• Patient Age: 27 YR
• Patient Sex: Female