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

Model Number	VICM512.6
Medical Device Problem Codes	Misfocusing (1401); Off-Label Use (1494)
Health Effect - Clinical Code	Blurred Vision (2137)
Type of Reportable Event	Malfunction
Event or Problem Description
The reporter indicated that the surgeon implanted a 12.6mm vicm5 12.6 implantable collamer lens of a -10.0 diopter as a replacement lens into the right eye (od) of a patient with pre-existing perilimabal on (b)(6) 2023, due to blurred vision and "od horizontal juxtaposed metamorphic eye." cause of the event is unknown and the problem was not resolved.Reportedly, "miochol was on back order miostate used ou for initial surgery.Pt has retinal eval pending although mocular oct shows no abnormalities when compared to preop moc oct.Appt (b)(6) 2023 - retina.".
Additional Manufacturer Narrative
A4-a6:unk.H6: off-label - pre-existing perilimabal.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 ; 1911 walker avenue; monrovia, CA 91016 ; 6263037902
• MDR Report Key: 17393777
• Report Number: 2023826-2023-03125
• Device Sequence Number: 5922255
• Product Code: MTA
• UDI-Device Identifier: 00841542119184
• UDI-Public: 00841542119184
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: P030016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/06/2023

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: 08/31/2024
• Device Model Number: VICM512.6
• 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: 07/06/2023
• Initial Report FDA Received Date: 07/25/2023
• Date Device Manufactured: 09/07/2022
• 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
• Patient Sex: Female