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

Model Number	VICM5 12.1
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	08/05/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H6-clinical code 4581: patient dissatisfaction with visual acuity.Claim# (b)(4).
Event or Problem Description
The reporter indicated that a 12.1mm vicm5 12.1 implantable collamer lens of -8.50 diopter was implanted into the patients right eye (od) on (b)(6) 2023.On (b)(6) 2023 the lens was explanted due to patient dissatisfaction-visual acuity due to age.The problem was resolved.
Additional Manufacturer Narrative
H3: device evaluation: lens returned in a microcentrifuge vial dry with residue/debris on product.Visual inspection haptic torn and residue on the lens.Claim#: (b)(4).
Additional Manufacturer Narrative
D9: returned to manufacturer date corrected to 09-nov-2023 in supplemental mdr#1.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: 18247920
• Report Number: 2023826-2023-05230
• Device Sequence Number: 6582853
• Product Code: MTA
• UDI-Device Identifier: 00840311300242
• UDI-Public: 00840311300242
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/16/2024

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: VICM5 12.1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/11/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/01/2023
• Supplement Date Received by Manufacturer: 01/18/2024; 02/16/2024
• Initial Report FDA Received Date: 12/01/2023
• Supplement Report FDA Received Date: 02/06/2024; 02/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/23/2022
• 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# UNK.; FOAM TIP PLUNGER (FTP), LOT# UNK.; INJECTOR MODEL: MSI-PF, LOT# UNK.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 45 YR
• Patient Sex: Female