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

Model Number	VICMO 13.7
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/13/2024
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.(b)(4).
Event or Problem Description
A healthcare professional reported that during an implantable collamer lens (icl) implantation procedure, the lens got stuck in the cartridge or injection system, but it was successfully implanted.In a separate visit, the lens was removed and later replaced in another surgery on the same date.No patient injury was reported, and the cause of the event was unknown.Additional information has been requested but none has been forthcoming.If additional information is received a supplemental medwatch report will be submitted.

• Brand Name: IMPLANTABLE COLLAMER LENS (ICL)
• Common Device Name: PHAKIC INTRAOCULAR LENS
• Manufacturer (Section D): STAAR SURGICAL; 1911 walker avenue; monrovia CA 91016
• Manufacturer (Section G): STAAR SURGICAL; 1911 walker avenue; monrovia CA 91016
• Manufacturer Contact: joselene muniz ; 1911 walker avenue; monrovia, CA 91016
• MDR Report Key: 20392794
• Report Number: 2023826-2024-04650
• Device Sequence Number: 12399268
• Product Code: MTA
• UDI-Device Identifier: 00840311302918
• UDI-Public: (01)00840311302918(11)230321(17)260228
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/12/2024

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: 02/28/2026
• Device Model Number: VICMO 13.7
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/12/2024
• Initial Report FDA Received Date: 10/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/21/2023
• 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 Age: 27 YR
• Patient Sex: Male