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	Blurred Vision (2137); Visual Disturbances (2140); Halo (2227); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/21/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D4 (expiration date); unk no serial number reported.D6a: unk.H4 (device manufacturing date): no serial number reported.(b)(4).
Event or Problem Description
A facility representative reported that following an implantable collamer lens (icl) implantation procedure, a possible lens exchange may be planned.If any additional information is received, a supplemental medwatch report will be submitted.There are multiple medical device reports associated with this patient.This report is 1 of 2 total reports.Based on the information provided, the risk assessment for our product, and our experience, we have determined the cause or contribution to the reported issue is not indicative of a manufacturing related issue or product deficiency.
Additional Manufacturer Narrative
Additional informaton: b5: a facility representative reported that following an implantable collamer lens (icl) implantation procedure, the patient experienced excessive vault, glare/halos, blurred vision, and headaches.Cause of the event is unknown.Claim# (b)(4).
Additional Manufacturer Narrative
B5: medication was used.Lens was removed.(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: 19945215
• Report Number: 2023826-2024-03604
• Device Sequence Number: 8113956
• Product Code: MTA
• UDI-Device Identifier: 00840311300853
• UDI-Public: 00840311300853
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted 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,Followup
• Report Date (Section B): 07/29/2024

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?: Yes
• Operator of Device: Health Professional
• 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: 07/29/2024
• Supplement Date Received by Manufacturer: 08/16/2024; 09/19/2024
• Initial Report FDA Received Date: 08/08/2024
• Supplement Report FDA Received Date: 08/27/2024; 10/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/10/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: CARTRIDGE MODEL: SFC-45 - LOT# UNK.; UNK.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 27 YR
• Patient Sex: Female