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

Model Number	VICM513.2
Medical Device Problem Code	Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/20/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A1: (b)(6).H6 - type of investigation - lens work order search: no similar complaint type events reported for units within the same lot.Claim# (b)(4).
Event or Problem Description
The reporter indicated that a 13.2mm vticmo13.2 implantable collamer lens of -3.50 diopter was implanted into the patient's right eye (od) on (b)(6) 2023.On (b)(6) 2023 the lens was explanted due to excessive vault and the problem resolved.
Additional Manufacturer Narrative
Corrected data: b5 - the reporter indicated that a 13.2mm vicm5_13.2 implantable collamer lens of -3.50 diopter was implanted into the patient's right eye (od) on (b)(6) 2023.On (b)(6) -2023 the lens was explanted due to excessive vault and the problem resolved.H3 - device evaluation: lens was returned dry and with residue/debris on the product in a microcentrifuge vial.Visual inspection found the optic (torn) and a haptic (broken) damaged.Overall length verification found the lens to be within specifications.Unable to perform width verification due to damaged state of the lens.Claim# (b)(4).
Additional Manufacturer Narrative
H6- device evaluation: lens was returned dry in a microcentrifuge vial.Visual inspection found the optic (torn) and a haptic (broken) damaged.Overall length verification found the lens to be within specifications.Unable to perform width verification due to damaged state of the lens.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
• MDR Report Key: 17262134
• Report Number: 2023826-2023-02698
• Device Sequence Number: 7966908
• Product Code: MTA
• UDI-Device Identifier: 00840311300808
• UDI-Public: 00840311300808
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2025
• Device Model Number: VICM513.2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/19/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/09/2023
• Supplement Date Received by Manufacturer: 08/14/2023; 12/16/2023
• Initial Report FDA Received Date: 07/05/2023
• Supplement Report FDA Received Date: 12/01/2023; 12/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/07/2022
• 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 W/FTP, LOT#UNK; INJECTOR MODEL: MSI-PF, LOT# UNK
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female