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

Model Number	VICM5 13.2
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Visual Disturbances (2140)
Date of Event	05/14/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A4-a6: unk.H6 - type of investigation: 4110 - 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 the surgeon implanted a 13.2mm vicm5_ 13.2 implantable collamer lens of diopter -8.50 as an exchange lens into the patient's right eye (od) to resolve glare/haloes and lens dislocation/subluxation on (b)(6) 2024.On (b)(6) 2024 the lens was explanted.The problem was resolved.Reportedly, "one size up and it was fixed, vertically, but at the time of examination the day after surgery, it was rotated and fixed horizontally and still deviated downward.So, the lens was removed." the cause of the event was reported as patient related factor - "suspected ciliary band fragility due to trauma.".
Additional Manufacturer Narrative
H3 device evaluation: the lens was returned with moisture a microcentrifuge vial.Visual inspection found no visible damage to the lens.Dimensional inspection found the lens to be within specifications.(b)(4).
Additional Manufacturer Narrative
H3 device evaluation 3331 device history record (dhr) review the device history records indicates that the product has been manufactured within the established process parameters and that there is no indication that the manufacturing and/or processing of the device contributed to the complaint issue.(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 ; 6263037902
• MDR Report Key: 19547747
• Report Number: 2023826-2024-02666
• Device Sequence Number: 4733987
• Product Code: MTA
• UDI-Device Identifier: 00840311300952
• UDI-Public: 00840311300952
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/30/2024

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 Model Number: VICM5 13.2
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/30/2024
• Supplement Date Received by Manufacturer: 10/29/2024; 10/30/2024
• Initial Report FDA Received Date: 06/17/2024
• Supplement Report FDA Received Date: 10/30/2024; 10/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/14/2024
• 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: UNK.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 30 YR
• Patient Sex: Male