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

Model Number	VTICM5 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
Event or Problem Description
A facility representative reported that the lens was too small.The lens was explanted and replaced, it is unknown if this happened within the same surgery and if this resolved the issue.Additional information was requested.No further information is available at this time.This file will be reopened if additional information is provided.
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
Upon further review, it has been determined that the event is not mdr reportable.There has been no report of serious injury or malfunction.Initial mdr is not applicable.
Additional Manufacturer Narrative
B5 - upon further review, it has been determined that the event is not mdr reportable.There has been no report of serious injury or malfunction.Initial mdr is not applicable.Claim (b)(4).

• Brand Name: IMPLANTABLE COLLAMER LENS (ICL)
• Common Device Name: PHAKIC TORIC 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 ; 800 royal oaks dr.; suite: 210; monrovia, CA 91106 ; 8002927902
• MDR Report Key: 21021726
• Report Number: 2023826-2024-05897
• Device Sequence Number: 3969287
• Product Code: QCB
• UDI-Device Identifier: 00840311305018
• UDI-Public: (01)00840311305018(11)230906(17)260831
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: Other,Foreign,Health Professional
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/04/2024

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: 08/31/2026
• Device Model Number: VTICM5 12.1
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/04/2024
• Supplement Date Received by Manufacturer: 01/14/2025
• Initial Report FDA Received Date: 12/26/2024
• Supplement Report FDA Received Date: 01/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/06/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: CARTRIDGE MODEL-SFC-45, LOT# UNK; FOAM TIP PLUNGER MODEL-FTP, LOT# UNK; INJECTOR MODEL-MSI-PF, LOT# UNK
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown