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

Model Number	VICM5_12.1
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/13/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The reporter indicated the surgeon implanted a 12.1mm vicm5_12.1 implantable collamer lens, -08.00 diopter, in the patients left eye (os), on (b)(6) 2023.This was the replacement lens for mfr.Report # 2023826-2023-01499, but the problem was not resolved, there is a possibility of replacement.The lens remained implanted.Additional information has been requested but none has been forthcoming.
Additional Manufacturer Narrative
A4: unk.A5: unk.A6: unk.D6b: unk.H6 - work order search: no similar complaint was reported for units within the same lot.Claim # (b)(4).
Additional Manufacturer Narrative
B5: the reporter indicated the patient has not returned to the clinic since the last follow-up.According to the surgeon, the patient does not seem to require further treatment for now.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 enriquez ; 1911 walker avenue; monrovia, CA 91016
• MDR Report Key: 16833350
• Report Number: 2023826-2023-01500
• Device Sequence Number: 7180491
• Product Code: MTA
• UDI-Device Identifier: 00840311300235
• UDI-Public: 00840311300235
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: P030016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted 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?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2025
• Device Model Number: VICM5_12.1
• 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: 03/30/2023
• Supplement Date Received by Manufacturer: 06/26/2023
• Initial Report FDA Received Date: 04/28/2023
• Supplement Report FDA Received Date: 07/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/25/2022
• 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
• Patient Age: 21 YR
• Patient Sex: Female