MAUDE Adverse Event Report: STAAR SURGICAL 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 Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/17/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Claim # (b)(4).
Event or Problem Description
A facility representative reported that following an implantable collamer lens (icl) implantation procedure, the patient experienced hight vault.Lens remains implanted.Additional information has been requested but none has been forthcoming.If additional information is received a supplemental medwatch report will be submitted.
Additional Manufacturer Narrative
B5: a facility representative reported that following an implantable collamer lens (icl) implantation procedure, the patient experienced excessive vault.In a separate visit the lens was explanted and later replaced for a shorter length lens.The problem resolved.Cause of event was reported as the device.Manufacturer narrative - secondary surgical intervention to remove/replace/reposition the lens is identified in the labeling as a known potential adverse event following icl implantation.Claim # (b)(4).

• Brand Name: IMPLANTABLE COLLAMER LENS (ICL)
• Common Device Name: PHAKIC INTRAOCULAR LENS
• Manufacturer (Section D): STAAR SURGICAL; 1911 walker avenue; monrovia CA 91016
• Manufacturer (Section G): STAAR SURGICAL; 1911 walker avenue; monrovia CA 91016
• Manufacturer Contact: joselene muniz ; 1911 walker avenue; monrovia, CA 91016
• MDR Report Key: 20560040
• Report Number: 2023826-2024-05001
• Device Sequence Number: 3102834
• Product Code: MTA
• UDI-Device Identifier: 00840311301126
• UDI-Public: (01)00840311301126(11)231101(17)260930
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/04/2024

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
• Device Expiration Date: 09/30/2026
• Device Model Number: VICM5_13.7
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/04/2024
• Supplement Date Received by Manufacturer: 10/29/2024
• Initial Report FDA Received Date: 10/29/2024
• Supplement Report FDA Received Date: 12/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/01/2023
• 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: INJECTOR MODEL: LIOLI-24, LOT# UNKNOWN
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 42 YR
• Patient Sex: Female