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

Model Number	VTICM5_12.1 (-5.0/1.0)
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/08/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H6: adverse event problem codes.4110: a lens work order search was performed.No similar complaints within associated lots were found.10: returned product evaluation - the subject lens was received in liquid within a microcentrifuge vial.Visual inspection found no visible damage to the lens.Dimensional inspection confirmed that the returned lens length did not conform to the labeled lens length.Functional inspection found the lens to be within specifications.3331: review of production records confirmed that this lens was manufactured to a length longer than the labelled parameter.A corrective and preventive action (capa) has been initiated to identify the root cause and develop mitigations.Claim: (b)(4).
Event or Problem Description
A facility representative reported that following an implantable collamer lens (icl) implantation procedure, the patient experienced excessive vault.The lens was later removed, and the problem was resolved.The reported cause of the event was the device.
Additional Manufacturer Narrative
3331: device history record review: additional comments - the root cause of the event was the use of an incorrect tool and/or machining file during the milling of the lens profile.This resulted in work order (b)(4) producing lenses with incorrect dimensions, as confirmed by optocraft imaging and the dimensional measurements taken during returned-product evaluation.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 SUGICAL COMPANY; 1911 walker avenue; monrovia CA 91016
• Manufacturer Contact: joselene muniz ; 1911 walker avenue; monrovia, CA 91016 ; 6263037902
• MDR Report Key: 23796828
• Report Number: 2023826-2025-01996
• Device Sequence Number: 18759733
• Product Code: QCB
• UDI-Device Identifier: 00840311304363
• UDI-Public: (01)00840311304363(11)241209(17)271130
• 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: 2025
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/03/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: VTICM5_12.1 (-5.0/1.0)
• Device Catalogue Number: VTICM5_12.1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/16/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/19/2025
• Supplement Date Received by Manufacturer: 02/12/2026
• Initial Report FDA Received Date: 12/12/2025
• Supplement Report FDA Received Date: 03/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/09/2024
• 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
• Patient Age: 44 YR
• Patient Sex: Male