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

Model Number	VICM513.2
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Codes	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/24/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The reporter indicated that 13.2mm vicm513.2 implantable collamer lens of a -10.0 diopter was implanted into the patient's left eye (os) on (b)(6) 2023."very shallow ac post icl" was reported.The problem was not resolved.Cause of the event was the device.
Additional Manufacturer Narrative
A4-a6: unk.H6: work order search: no similar complaints within associated lots were found.Claim# (b)(4).
Additional Manufacturer Narrative
The reporter indicated the surgeon implanted a 13.2mm vicm5_13.2 implantable collamer lens of diopter -10.00 into the patient's left eye (os) on (b)(6) 2023.The patient experienced a shallow anterior chamber.The lens remains implanted.The problem was not resolved.Status of the eye: "good va".The reporter indicated the cause of the event was the device.Health effect - clinical code: "4581- shallow anterior chamber" should be added.Claim# (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 ; 800 royal oaks dr. suite: 210; monrovia, CA 91016 ; 6263037902
• MDR Report Key: 18121662
• Report Number: 2023826-2023-04971
• Device Sequence Number: 7540632
• Product Code: MTA
• UDI-Device Identifier: 00841542119412
• UDI-Public: 00841542119412
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: P030016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/31/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/31/2024
• Device Model Number: VICM513.2
• 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: 10/31/2023
• Supplement Date Received by Manufacturer: 02/06/2024
• Initial Report FDA Received Date: 11/13/2023
• Supplement Report FDA Received Date: 02/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/15/2022
• 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 - 1635505; FOAM TIP PLUNGER - LOT# 1654343; INJECTOR MODEL: MSI-PF - 1626639
• Patient Age: 43 YR
• Patient Sex: Female