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

Model Number	VTICMO 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	12/31/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H6 - investigation type 4110: lens work order search - no similar complaint event(s) within associated lots were found.Claim#(b)(4).
Event or Problem Description
The reporter indicated that the surgeon implanted a 12.6mm vticmo12.6 -15.0/2.0/070 (sphere/cylinder/axis) implantable collamer lens into the patient's left eye (os) on (b)(6)2023.Lens rotation not associated to a low vault was observed.Lens was replaced on (b)(6) 2024 with a longer length lens and problem was resolved.Cause of event was reported as unknown.
Additional Manufacturer Narrative
H3: device evaluation lens was returned in microcentrifuge vial with moisture and residue/debris on product.Visual inspection found haptic bent.Dimensional inspection found the lens to be within specification.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 ; 800 royal oaks dr; suite 210; monrovia, CA 91016 ; 6263037902
• MDR Report Key: 19551772
• Report Number: 2023826-2024-02690
• Device Sequence Number: 17820331
• Product Code: QCB
• UDI-Device Identifier: 00840311323128
• UDI-Public: 00840311323128
• Combination Product (Y/N): N
• Initial Reporter Country: HK
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/02/2024

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: 05/31/2026
• Device Model Number: VTICMO 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: 06/02/2024
• Supplement Date Received by Manufacturer: 09/27/2024
• Initial Report FDA Received Date: 06/17/2024
• Supplement Report FDA Received Date: 09/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/19/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 28 YR
• Patient Sex: Male