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

Model Number	VICM5_13.2
Medical Device Problem Codes	Off-Label Use (1494); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Blurred Vision (2137); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/18/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
The reporter indicated that the surgeon implanted a 13.2mm vicm5_13.2 implantable collamer lens of diopter -5.50 into the patient's right eye (od) on (b)(6) 2024.The patient experienced an excessive vault and blurred vision.On (b)(6) 2024, the lens was explanted.On the same day the lens was replaced with the same model, shorter length and the problem was resolved.Status of the eye: "perfect".The reporter indicated the device did not fail to perform as intended.Cause details provided: "lens too large".
Additional Manufacturer Narrative
Medical device problem code: 1494- off label use (age>45yrs) (b)(4).

• Brand Name: IMPLANTABLE COLLAMER LENS (ICL)
• Common Device Name: PHAKIC 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 ; 1911 walker avenue; monrovia, CA 91016 ; 6263037902
• MDR Report Key: 19243996
• Report Number: 2023826-2024-02121
• Device Sequence Number: 6949138
• Product Code: MTA
• UDI-Device Identifier: 00841542119320
• UDI-Public: 00841542119320
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P030016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/01/2024

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: 07/31/2024
• Device Model Number: VICM5_13.2
• 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: 05/01/2024
• Initial Report FDA Received Date: 05/03/2024
• Date Device Manufactured: 01/19/2024
• 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 (FTP), LOT# UNK; MSI-PF, LOT# UNK
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 53 YR
• Patient Sex: Male