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)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A4-a6:unk h6: work order search: no similar complaints within associated lots were found.Claim# (b)(4).
Event or Problem Description
The reporter indicated that a 13.2mm vicm513.2 implantable collamer lens of a 8.0 diopter was intraoperatively implanted and removed from the patient's left eye (os) on (b)(6) 2023.The problem was resolved.
Additional Manufacturer Narrative
H3 - device evaluation: the lens was returned with moisture in a microcentrifuge vial.Visual inspection found no visible damage.Claim # (b)(4).
Additional Manufacturer Narrative
B5 - the reporter indicated that the surgeon implanted a 13.2mm vicm5_13.2 implantable collamer lens of diopter -8.0 into the patient's left eye (os) on (b)(6) 2023.The lens was implanted, removed and replaced the same day with a same model and length lens.It is not known if this was done intraoperatively.This resolved the problem.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 dr. suite: 210; monrovia, CA 91016 ; 6263037902
• MDR Report Key: 18540560
• Report Number: 2023826-2024-00265
• Device Sequence Number: 20778286
• Product Code: MTA
• UDI-Device Identifier: 00840311300891
• UDI-Public: 00840311300891
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• 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,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/05/2024

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: 07/31/2026
• Device Model Number: VICM513.2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/11/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/05/2024
• Supplement Date Received by Manufacturer: 03/20/2024; 03/20/2024
• Initial Report FDA Received Date: 01/18/2024
• Supplement Report FDA Received Date: 03/25/2024; 03/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/25/2023
• 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.
• Patient Sex: Male