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

Model Number	VICM513.2
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/28/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H6: work order search: one similar complaint was found within associated lots.Claim# (b)(4).Claim# (b)(4).
Event or Problem Description
The reporter indicated that 13.2mm vicm513.2 implantable collamer lens of a -9.0 diopter tore/broke during injection into the patient's right eye (od) on (b)(6) 2023.There was patient contact, but no patient injury.Cause of the event was the device.Reportedly, "injector/cartridge - defective lot," and "lens defect in periphery leaving unless patient reports problem & va per jls".
Additional Manufacturer Narrative
D10: lioli lot# fck1702.Claim# (b)(4).
Additional Manufacturer Narrative
B5 - lens was intraoperatively implanted, removed and replaced.Claim# (b)(4).
Additional Manufacturer Narrative
B5: lens was removed and replaced.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: 17401157
• Report Number: 2023826-2023-03122
• Device Sequence Number: 7556756
• Product Code: MTA
• UDI-Device Identifier: 00841542119399
• UDI-Public: 00841542119399
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• 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: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• 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: 10/31/2024
• Device Model Number: VICM513.2
• 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: 07/06/2023
• Supplement Date Received by Manufacturer: 08/18/2023; 09/19/2023; 12/15/2023
• Initial Report FDA Received Date: 07/26/2023
• Supplement Report FDA Received Date: 08/22/2023; 09/19/2023; 12/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/14/2022
• 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: LIOLI - LOT# FCK1702; INJECTOR MODEL: LIOLI - LOT# UNK
• Patient Age: 22 YR
• Patient Sex: Female