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

Model Number	VICM5_12.6
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Codes	Halo (2227); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	08/04/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Health effect clinical code: 4581 - starburst, diplopia, claim#: (b)(4).
Event or Problem Description
The reporter indicated that the surgeon implanted a 12.6mm vicm5_12.6, -10.5 diopter implantable collamer lens into the patient's left eye (os) on (b)(6) 2023.The surgeon reports there was lens rotation, halos, starburst, diplopia, the lens was repositioned on (b)(6) 2023 the lens was repositioned but this did not resolve the problem.On (b)(6) 2023 the lens was exchanged with a longer length lens and the problem was resolved and it was noted "vault is higher but ok, lens is centered".The cause of the event was reported as a patient related factor with no device causality and noted "descentration caused short length".
Additional Manufacturer Narrative
Corrected information: b5 - decentration should have been included.H6 - health effect clinical code: 4581 - decentration claim#: (b)(4).
Additional Manufacturer Narrative
Device evaluation: the lens was returned with moisture in a microcentrifuge vial.Visual inspection found haptic broken.Dimensional inspection width could not be performed due to haptic damage.Overall length was found within specifications.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 SURGICAL COMPANY; 1911 walker avenue; monrovia CA 91016
• Manufacturer Contact: joselene muniz ; 1911 walker avenue; monrovia, CA 91016
• MDR Report Key: 17770483
• Report Number: 2023826-2023-04112
• Device Sequence Number: 17893682
• Product Code: MTA
• UDI-Device Identifier: 00840311300617
• UDI-Public: 00840311300617
• Combination Product (Y/N): N
• Initial Reporter Country: AR
• PMA/510(K) Number: P030016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/28/2023

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: 01/31/2026
• Device Model Number: VICM5_12.6
• 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: 08/28/2023
• Supplement Date Received by Manufacturer: 11/25/2023; 01/08/2024
• Initial Report FDA Received Date: 09/18/2023
• Supplement Report FDA Received Date: 11/25/2023; 05/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/26/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 31 YR
• Patient Sex: Male