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

Model Number	VICM5 13.2
Medical Device Problem Codes	Off-Label Use (1494); Patient-Device Incompatibility (2682); No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/07/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D4 (experiation date); unk no serial number reported.H4 (device manufacturing date): no serial number reported.Claim# (b)(4).
Event or Problem Description
The reporter indicated that a 13.2mm vicm513.2 implantable collamer lens of a -11.0 diopter was implanted into the patient's right eye (od).Reportedly, "hyperopic surprise on a patient.".
Additional Manufacturer Narrative
B5: the implantable collamer lens was implanted into the patient's right eye (od) on (b)(6)2023.Cause of the event was a patient-related-factor with the device not performing as intended.Reportedly, "patient is challenging to refract and easy to overminus." h6: patient related factor off-label use: age<45.(b)(4).
Additional Manufacturer Narrative
Claim# (b)(4).
Additional Manufacturer Narrative
B5 - lens was explanted.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.; monrovia, CA 91016 ; 6263037902
• MDR Report Key: 17864496
• Report Number: 2023826-2023-04381
• Device Sequence Number: 14970691
• Product Code: MTA
• UDI-Device Identifier: 00841542119436
• UDI-Public: 00841542119436
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: UNK
• 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: Foreign,Study,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 09/27/2023

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2024
• Device Model Number: VICM5 13.2
• 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: 09/27/2023
• Supplement Date Received by Manufacturer: 10/11/2023; 10/11/2023; 11/07/2023
• Initial Report FDA Received Date: 10/03/2023
• Supplement Report FDA Received Date: 10/11/2023; 10/16/2023; 12/05/2023
• Date Device Manufactured: 08/16/2022
• 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: INJECTOR MODEL: LIOLI-24 - LOT# UNK
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 49 YR
• Patient Sex: Female