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

Model Number	VTICM5 13.2
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Visual Disturbances (2140); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/13/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A4-a6: unk claim #(b)(4).
Event or Problem Description
The reporter indicated that the surgeon implanted a 13.2mm vticm5_13.2 implantable collamer lens of diopter -13.5/1.0/068 (sphere/cylinder/axis) into the patient's right eye (od) on (b)(6) 2023.On (b)(6) 2024 the lens was explanted due to excessive vault, glare/haloes, and iris atrophy.On (b)(6) 2024 a replacement lens of a shorter length was implanted.The problem was resolved.The cause of the event was reported as the device due to ']vault high; peculiar ac.'.
Additional Manufacturer Narrative
B5 - corrected to: originally the claim was determined to be reportable, but upon further review was determined to not meet definition of a complaint.However, the claim cannot be voided as an mdr has already been submitted.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: 19140410
• Report Number: 2023826-2024-01866
• Device Sequence Number: 7444084
• Product Code: QCB
• UDI-Device Identifier: 00841542117067
• UDI-Public: 00841542117067
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• 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: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/10/2024

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: 09/30/2024
• Device Model Number: VTICM5 13.2
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• 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: Not provided
• Supplement Date Received by Manufacturer: 05/01/2024
• Initial Report FDA Received Date: 04/18/2024
• Supplement Report FDA Received Date: 05/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/31/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: CARTRIDGE MODEL: SFC-45 - LOT# UNK; FOAM TIP PLUNGER - LOT# UNK; INJECTOR MODEL: MSI-TF - LOT# UNK
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 28 YR
• Patient Sex: Female