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

Model Number	VICM5 12.6
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/30/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The reporter indicated that the surgeon implanted and removed a 12.6mm vicm5_12.6.-6.0 diopter, implantable collamer lens into the patient's right eye (od) on (b)(6) 2023.The lens tore/broke during injection/delivery into the eye.There was patient contact(lens touched the eye).No patient injury.The lens was exchanged with a longer length lens on (b)(6) 2023.This resolved the problem.
Additional Manufacturer Narrative
H6 - work order search: no similar complaint type events were reported for units within the same lot.Claim# (b)(4).
Additional Manufacturer Narrative
B5- the reporter indicated that the surgeon implanted a 12.6mm vicm5_12.6 implantable collamer lens of dipper -6.00 into the patients right eye (od) on (b)(6) 2023.Reportedly the lens tore/broke during injection/delivery into the eye.The lens was implanted, removed and replaced intraoperatively with a lens of the same model and power, shorter length and the problem was resolved 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 muniz ; 1911 walker avenue; monrovia, CA 91016
• MDR Report Key: 18525772
• Report Number: 2023826-2024-00169
• Device Sequence Number: 6411662
• Product Code: MTA
• UDI-Device Identifier: 00840311300525
• UDI-Public: 00840311300525
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• 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): 12/27/2023

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: 12/31/2025
• Device Model Number: VICM5 12.6
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• 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: 12/27/2023
• Supplement Date Received by Manufacturer: 02/22/2024
• Initial Report FDA Received Date: 01/17/2024
• Supplement Report FDA Received Date: 03/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/10/2023
• 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: CARTRIDGE MODEL#SFC-45,LOT#UNK; FOAMTIPPLUNGER MODEL#FTP,LOT#UNK; INJECTOR MODEL#MSI-PF,LOT#UNK
• Patient Age: 24 YR
• Patient Sex: Female