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

Model Number	VICM5_13.7
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); No Apparent Adverse Event (3189)
Health Effect - Clinical Codes	Uveitis (2122); Visual Disturbances (2140); Halo (2227); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/19/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
A facility representative reported that following an implantable collamer lens (icl) implantation procedure, excessive vault was observed.The lens remains implanted.Additional information was requested.No further information is available at this time.This file will be re-opened if additional information is provided.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
A4-a6:unk b3: unk d4 (experiation date); unk no serial number reported.D6a: unk h4 (device manufacturing date): no serial number reported.Claim# (b)(4).
Additional Manufacturer Narrative
Claim# (b)(4).
Additional Manufacturer Narrative
B5: a facility representative reported that following an implantable collamer lens (icl) implantation procedure, a patient with pre-existing retinal holes, experienced excessive vault, glare/halos, and uvetis/iritis.Reportedly, the patient had laser retinopexy, no diabetic retinopathy, drusen.The lens remains implanted.Cause was reported as the device.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.H6: work order search: 1 similar complaints within associated lots was found.Fellow eye claim# (b)(4).
Additional Manufacturer Narrative
H6: device history record review indicates that the product has been manufactured within the established process parameters and that there is no indication that the manufacturing and/or processing of the device contributed to the complaint issue.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: 20588654
• Report Number: 2023826-2024-05049
• Device Sequence Number: 6550967
• Product Code: MTA
• UDI-Device Identifier: 00840311301164
• UDI-Public: (01)00840311301164(11)231017(17)260930
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: UNK
• 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,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 10/16/2024

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: 09/30/2026
• Device Model Number: VICM5_13.7
• 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: 10/16/2024
• Supplement Date Received by Manufacturer: 11/12/2024; 01/06/2025; 01/24/2025
• Initial Report FDA Received Date: 11/01/2024
• Supplement Report FDA Received Date: 11/14/2024; 01/09/2025; 01/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/17/2023
• 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; FOAM TIP PLUNGER - LOT# UNK; INJECTOR MODEL: MSI-PF - LOT# UNK
• Patient Age: 38 YR
• Patient Sex: Male