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

Model Number	VTICMO12.6
Medical Device Problem Codes	Off-Label Use (1494); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Eye Pain (4467); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/01/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
The reporter indicated the surgeon implanted a 12.6mm vticmo12.6 implantable collamer lens, -14.50/+2.0/115 (sphere/cylinder/axis), in the patients right eye (od), on (b)(6) 2023.The lens was explanted on (b)(6) 2023 due to patient was experiencing orbital pain due to psychological effects and the problem was resolved.Additional information has been requested but none has been forthcoming.
Additional Manufacturer Narrative
A4: unk a5: unk a6: unk h6 - device code: 1494 - this lens model is contraindicated for patients with an anterior chamber depth (acd) less than 3.0mm.H6 - work order search: no similar complaint was reported for units within the same lot.Claim # (b)(4).
Additional Manufacturer Narrative
Corrected data: b5: the reporter indicated the surgeon implanted a 12.6mm vticmo12.6 implantable collamer lens, -14.50/+2.0/115 (sphere/cylinder/axis), into the patients right eye (od) on (b)(6) 2023.The lens was explanted on (b)(6) 2023 due to the patient had a sense of shaking and could not adapt himself, so he requested the icl be removed.The surgeon felt that it may be related to the abnormal adjustment function of the patient.The patient would not cooperated with the later examination and treatment.The problem was resolved.H6: health effect: clinical code (e): 4582 (patient did not have any pain).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 ; 1911 walker avenue; monrovia, CA 91016 ; 6263037902
• MDR Report Key: 18387537
• Report Number: 2023826-2023-05730
• Device Sequence Number: 14143107
• Product Code: QCB
• UDI-Device Identifier: 00840311323111
• UDI-Public: 00840311323111
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/11/2023

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: 11/30/2025
• Device Model Number: VTICMO12.6
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/11/2023
• Supplement Date Received by Manufacturer: 02/19/2024
• Initial Report FDA Received Date: 12/22/2023
• Supplement Report FDA Received Date: 02/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/20/2022
• 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: 39 YR
• Patient Sex: Male