MAUDE Adverse Event Report: STAAR SURGICAL COMPANY IMPLANTABLE COLLAMER LENS (ICL); PHAKIC TORIC 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)
Date of Event	09/11/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H11 manufacturer narrative - : icl may move out of its appropriate position, secondary surgical intervention to remove/replace/reposition the lens is identified in the labeling as a known potential adverse event following icl implantation.Claim# (b)(4).
Event or Problem Description
A facility representative reported that an implantable collamer lens was implanted into the patient's eye.The patient experienced lens rotation not associated to a low vault.The lens was replaced with a longer length lens and the problem resolved.The cause of the event was reported as patient-related factor.
Additional Manufacturer Narrative
H3 - device evaluation: the lens was returned in liquid a vial.Visual inspection found no visible damage to the lens.Dimensional inspection found the lens to be within specifications.Claim # (b)(4).
Additional Manufacturer Narrative
H6- investigation type 4110: lens work order search-no similar complaints reported for units within the same lot.Claim # (b)(4).

• Brand Name: IMPLANTABLE COLLAMER LENS (ICL)
• Common Device Name: PHAKIC TORIC 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 ; 1911 walker ave; monrovia, CA 91016
• MDR Report Key: 20253227
• Report Number: 2023826-2024-04416
• Device Sequence Number: 8637816
• Product Code: QCB
• UDI-Device Identifier: 00840311305285
• UDI-Public: (01)00840311305285(11)220901(17)250731
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/30/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2025
• Device Model Number: VTICM5 12.1
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• 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: 08/30/2024
• Supplement Date Received by Manufacturer: 11/13/2024; 12/10/2024
• Initial Report FDA Received Date: 09/19/2024
• Supplement Report FDA Received Date: 12/07/2024; 12/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/01/2022
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 25 YR
• Patient Sex: Female