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

Model Number	VICM512.6
Medical Device Problem Code	Misfocusing (1401)
Health Effect - Clinical Code	Blurred Vision (2137)
Date of Event	03/20/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
The reporter indicated that a 13.2mm vicm513.2 implantable collamer lens of a -6.5 diopter was implanted into the patient's right eye (od) on (b)(6) 2023.On (b)(6) 2023, the lens was exchanged for a replacement lens due to refractive surprise.The problem was resolved.The cause of the event is unknown.Status of the eye is reported as "good.".
Additional Manufacturer Narrative
H6: work order search found no similar complaints.Claim# (b)(4).
Additional Manufacturer Narrative
H3: device evaluation - lens was returned in microcentrifuge vial in liquid.Visual inspection found optic and haptic torn.Unable to perform lens width due to haptic damage, lenses have been switched in yellow bags while returning.Dimensional and functional inspection found that the returned lens did not meet original values measured at the time of manufacturing.H6: device history record (dhr) review: based on the results of the investigation, all released devices from the associated work order(s), including the suspected device; have been manufactured within established process parameters; and there is no indication that the manufacturing and processing of the device contributed to the complaint issue.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: 16810453
• Report Number: 2023826-2023-01481
• Device Sequence Number: 20378737
• Product Code: MTA
• UDI-Device Identifier: 00840311300860
• UDI-Public: 00840311300860
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/30/2023

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: 09/30/2025
• Device Model Number: VICM512.6
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/19/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/30/2023
• Supplement Date Received by Manufacturer: 05/30/2023
• Initial Report FDA Received Date: 04/25/2023
• Supplement Report FDA Received Date: 05/31/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/10/2022
• 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 - LOT# UNK.; FOAM TIP PLUNGER LOT# UNK.; INJECTOR MODEL: MSI-PF - LOT# UNK.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 36 YR
• Patient Sex: Male