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

Model Number	VTICM5 12.6
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	05/13/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(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.In a separate visit the lens was repositioned, this did not resolve the problem.In a third visit the lens was exchanged for lens of the same length but different model and power.The problem was resolved.Cause of the event it is unknown.No additional similar complaint types were within associated lots were found.Additional information provided: "lasek performed for astigmatism".No patient injury reported.It should be noted that the surgeon selected a different lens size than that suggested by the icl software.Therefore, there is not enough safety and effectiveness data to support implantation in this patient category.
Additional Manufacturer Narrative
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.Claim (b)(4).
Additional Manufacturer Narrative
B4 - 14-apr-2025.E1 - (b)(6).E2 - yes.E3 - health professional.G3 - 30-dec-2024.H3 - yes.H6 - health impact type code: 4628 device repositioning.H3 - type of investigation code: 10- device evaluation: lens returned in a microcentrifuge vial dry, with reside/debris on product.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.H6- investigation type code: 4110- lens work order search-no similar complaint event(s) within associated lots were found.
Additional Manufacturer Narrative
E1 - (b)(6).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: 21203145
• Report Number: 2023826-2025-00119
• Device Sequence Number: 12780304
• Product Code: QCB
• UDI-Device Identifier: 00840311308422
• UDI-Public: (01)00840311308422(11)230909(17)260831
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: P030016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 04/24/2025

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: 08/31/2026
• Device Model Number: VTICM5 12.6
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/31/2024
• Supplement Date Received by Manufacturer: 03/26/2025; 12/30/2024; 04/24/2025
• Initial Report FDA Received Date: 01/21/2025
• Supplement Report FDA Received Date: 03/27/2025; 04/17/2025; 04/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/09/2023
• 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 Age: 30 YR
• Patient Sex: Male