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

Model Number	VTICMO 13.2
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	11/20/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Claim (b)(4).
Event or Problem Description
A facility representative reported that following an implantable collamer lens (icl) implantation procedure, the patient experienced lens rotation not associated with low vault.At a later date, the lens was exchanged for a longer length lens of the same model and power.Cause of the event is unknown.The problem was resolved.
Additional Manufacturer Narrative
H6- investigation type code: 4110- lens work order search-no similar complaint event(s) within associated lots were found.Claim (b)(4).
Additional Manufacturer Narrative
H4 - 4.Device manufacture date: 20-nov-2024 corrected 05-oct-2023.Claim (b)(4).
Additional Manufacturer Narrative
H3 - device evaluation: the lens was returned dry in a microcentrifuge tube.Visual inspection found no visible damage to the lens.Dimensional inspection found the lens to be within specifications.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 91016 ; 8002927902
• MDR Report Key: 21080094
• Report Number: 2023826-2025-00055
• Device Sequence Number: 15534407
• Product Code: QCB
• UDI-Device Identifier: 00840311328918
• UDI-Public: (01)00840311328918(11)231005(17)260930
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 12/12/2024

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: 09/30/2026
• Device Model Number: VTICMO 13.2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/12/2024
• Supplement Date Received by Manufacturer: 03/21/2025; 05/30/2025; 01/09/2026
• Initial Report FDA Received Date: 01/06/2025
• Supplement Report FDA Received Date: 03/21/2025; 05/30/2025; 01/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/20/2024
• 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: CARTRIDGE MODEL-SFC-45, LOT# UNK.; FOAM TIP PLUNGER MODEL-FTP, LOT# UNK.; INJECTOR MODEL-MSI-PF, LOT# UNK.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male