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	11/08/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The reporter indicated that 13.2mm vicm513.2 implantable collamer lens of a -9.5 diopter tore/broke while injection into the patient's eye.The back up lens was implanted.No patient injury was reported.
Additional Manufacturer Narrative
A4-a6:unk.H6: work order search: no similar complaints within associated lots were found.Claim# (b)(4).
Additional Manufacturer Narrative
B5 - the reporter indicated that 13.2mm vicm513.2 implantable collamer lens of a -9.5 diopter tore/broke while injection/delivery into the patient's left eye (os) on (b)(6) 2023.The lens was implanted, removed, and replaced intraoperatively within the initial surgery for a longer length lens.This resolved the problem.No patient injury was reported.Cause reported as unknown.D6a - (b)(6) 2023.D6b - (b)(6) 2023.H6 - health effect - impact code 2199 corrected to 4629.Claim # (b)(4).
Additional Manufacturer Narrative
B5 - the reporter indicated that a 13.2mm vicm513.2 implantable collamer lens of a -9.5 diopter tore/broke during injection/delivery into the patient's left eye (os) on (b)(6) 2023.The lens was implanted, removed, and replaced intraoperatively within the initial surgery for a same model and length 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 SUGICAL COMPANY; 1911 walker avenue; monrovia CA 91016
• Manufacturer Contact: joselene muniz ; 800 royal oaks suite:210; monrovia, CA 91016 ; 6263037902
• MDR Report Key: 18196858
• Report Number: 2023826-2023-05089
• Device Sequence Number: 17780582
• Product Code: MTA
• UDI-Device Identifier: 00841542119405
• UDI-Public: 00841542119405
• 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: 2023
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/11/2023

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: 03/31/2025
• 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: 11/08/2023
• Supplement Date Received by Manufacturer: 11/28/2023; 11/28/2023
• Initial Report FDA Received Date: 11/22/2023
• Supplement Report FDA Received Date: 12/11/2023; 12/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/24/2023
• 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: UNK.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 32 YR
• Patient Sex: Unknown