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

Model Number	MICL 12.1
Medical Device Problem Code	Misfocusing (1401)
Health Effect - Clinical Codes	Cataract (1766); Blurred Vision (2137)
Date of Event	03/22/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
The reporter indicated that a 12.1mm micl12.1 implantable collamer lens of -11.50 diopter was implanted into the patient's right eye (od) on (b)(6) 2023.On (b)(6) 2023 the lens was explanted due to refractive surprise and lens opacity.It was reported that refractive treatment and phaco-emulsification with iol implantation was performed and the problem resolved.The reporter states that the device failed to perform as intended, for cause details the reporter stated " the refractive surprise resulted in a hyperopic lvc (laser vision correction) and unsatisfactory vision.The asc was of lesser issue".
Additional Manufacturer Narrative
H6- health effect- impactl code 4625: refractive treatment and cataract surgery with iol implantation.H6 - type of investigation - lens work order search: no similar complaint type events reported for units within the same lot.Claim#: (b)(4).
Additional Manufacturer Narrative
B5 - the reporter indicated that a 12.1mm micl12.1 implantable collamer lens of -11.50 diopter was implanted into the patient's right eye (od) on (b)(6) 2022.H3 - device evaluation: the lens was returned with moisture and residue/debris on the lens in a vial.Visual inspection found no visible damage to the lens with foreign material on lens surface specifically residue throughout the lens.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: 17547267
• Report Number: 2023826-2023-03522
• Device Sequence Number: 20497476
• Product Code: MTA
• UDI-Device Identifier: 00841542102780
• UDI-Public: 00841542102780
• Combination Product (Y/N): N
• Initial Reporter State: OK
• 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: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/17/2023

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: 06/30/2023
• Device Model Number: MICL 12.1
• 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: 07/17/2023
• Supplement Date Received by Manufacturer: 10/19/2023
• Initial Report FDA Received Date: 08/14/2023
• Supplement Report FDA Received Date: 10/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/31/2021
• 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: 43 YR
• Patient Sex: Male