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

Model Number	VICM5_12.6
Medical Device Problem Codes	Misfocusing (1401); Off-Label Use (1494)
Health Effect - Clinical Code	Blurred Vision (2137)
Date of Event	09/13/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
The reporter indicated that a 12.6mm vicm5_12.6, -8.0 diopter implantable collamer lens was implanted into the patient's left eye (os) on (b)(6) 2022.It was reported that limbal relaxing incisions (lris) were made to reduce astigmatism but it did not reduce the expected amount.On (b)(6) 2022 the lens was exchanged for a toric lens to address the astigmatism (high cylinder power) and the problem resolved.In the reporters opinion the cause of this event was user error, product did not fail to perform as intended.
Additional Manufacturer Narrative
Additional information: h6: device code 1494- off label use- patient acd<3.00mm.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 enriquez ; 1911 walker avenue; monrovia, CA 91016 ; 8002927902
• MDR Report Key: 15640127
• Report Number: 2023826-2022-03703
• Device Sequence Number: 6444540
• Product Code: MTA
• UDI-Device Identifier: 00841542119146
• UDI-Public: 00841542119146
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: P030016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• 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): 09/20/2022

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: 04/30/2024
• Device Model Number: VICM5_12.6
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/07/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/20/2022
• Supplement Date Received by Manufacturer: 11/11/2022
• Initial Report FDA Received Date: 10/20/2022
• Supplement Report FDA Received Date: 12/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/13/2022
• 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: CARTRIDGE MODEL: SFC-45 W/FTP, LOT# UNK; INJECTOR MODEL: MSI-PF, LOT# UNK
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 45 YR
• Patient Sex: Female