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	Blurred Vision (2137)
Type of Reportable Event	Serious Injury
Event or Problem Description
A facility representative reported that following an implantable collamer lens (icl) implantation procedure, the patient experienced refractive surprise.In a separate visit the lens was exchanged for a lens of a different diopter.Cause reported as unknown.The problem was resolved.No additional similar complaint types were found.
Additional Manufacturer Narrative
Claim (b)(4).
Additional Manufacturer Narrative
E1 - (b)(6).E2 - yes.E3 - health professional.H3 - type of investigation code: 10- device evaluation: the lens was returned with moisture in a microcentrifuge vial.Visual inspection found no visible damage to the lens.Dimensional inspection found the returned lens did meet original values measured at the time of manufacturing.Functional inspection found the lens did not meet original values at the time of manufacturing.H6- investigation type code: 4110- lens work order search-no similar complaint event(s) within associated lots were found.H6 - investigation type code: 3331 - device history record found associated source lots were manufactured within established parameters.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: 21296241
• Report Number: 2023826-2025-00120
• Device Sequence Number: 15784810
• Product Code: QCB
• UDI-Device Identifier: 00840311326730
• UDI-Public: (01)00840311326730(11)230812(17)260731
• 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: 2023
• Device Explanted Year: 2023
• 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): 01/08/2025

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: VTICMO 13.2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/16/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/08/2025
• Supplement Date Received by Manufacturer: 03/05/2025
• Initial Report FDA Received Date: 02/03/2025
• Supplement Report FDA Received Date: 04/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/12/2023
• 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: Required Intervention
• Patient Sex: Male