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

Model Number	VICM5 12.1
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Claim#(b)(4).
Event or Problem Description
The reporter indicated the surgeon implanted a 12.1 mm vicm5_12.1; -7.50 diopter implantable collamer lens into the patient's eye upside down.Reportedly " he simply implanted upside down ordered replacement, removed upside down lens, implanted new one in correct orientation, patient is doing great.".No post exchange data was provided.Additional information was requested but has not been provided to date.
Additional Manufacturer Narrative
Additional data: h6 - work order search: no similar complaint was reported for units within the same lot.Corrected data: d4: primary unique device identifier (udi) #: (b)(4)."udi related data quality updates only" d9: is this device available for evaluation? returned to manufacturer: 20-jun-2024.Claim # (b)(4).

• Brand Name: IMPLANTABLE COLLAMER DEVICE (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: 19645811
• Report Number: 2023826-2024-02823
• Device Sequence Number: 15391331
• Product Code: MTA
• UDI-Device Identifier: 00840311300228
• UDI-Public: (01)00840311300228(11)230823(17)260731(21)S2115282
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• 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: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/01/2024

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
• Device Expiration Date: 07/31/2026
• Device Model Number: VICM5 12.1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/27/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/05/2024
• Supplement Date Received by Manufacturer: 09/19/2024
• Initial Report FDA Received Date: 07/01/2024
• Supplement Report FDA Received Date: 10/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/23/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown