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

Model Number	VTICMO13.2
Medical Device Problem Code	Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/26/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H6: work order search: no similar complaints within associated lots were found.Claim# (b)(4).
Event or Problem Description
The reporter indicated that a 13.2mm vticmo13.2 implantable collamer lens of -16.0/2.0/094 (sphere/cylinder/axis) was implanted into the patient's left eye (os) on (b)(6) 2023.On (b)(6) 2023, the lens was exchanged for a shorter length lens due to excessive vault.The problem was not resolved.Reportedly, "during the re-implantation process, the icl was broken during the injection, and the operation was performed after re-ordering the lens.Cause of the event is unknown.
Additional Manufacturer Narrative
D9: return date: 14-nov-2023.Device evaluation: the lens was returned with moisture in a microcentrifuge vial.Visual inspection found the device returned severely damaged.Visual and dimensional inspections were unable to be performed due to the lens returned with the optic torn and the haptic broken with residue/debris on the lens.(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 91016 ; 6263037902
• MDR Report Key: 17951047
• Report Number: 2023826-2023-04483
• Device Sequence Number: 6715551
• Product Code: QCB
• UDI-Device Identifier: 00840311327461
• UDI-Public: 00840311327461
• 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): 10/07/2023

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: 12/31/2025
• Device Model Number: VTICMO13.2
• 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: 10/07/2023
• Supplement Date Received by Manufacturer: 12/19/2023
• Initial Report FDA Received Date: 10/17/2023
• Supplement Report FDA Received Date: 01/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/27/2023
• 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: 26 YR
• Patient Sex: Male