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	03/23/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The reporter indicated a 12.6mm vicm5_12.6 implantable collamer lens, -11.00 diopter, tore before loading and there was no patient contact.The lens was replaced with another same model/length lens and the problem was resolved.The cause of the event was unknown.
Additional Manufacturer Narrative
A4: unk, a5: unk, a6: unk, h6 - work order search: no similar complaint was reported for units within the same lot.Claim # (b)(4).
Additional Manufacturer Narrative
Corrected data: b5- the reporter indicated the surgeon noted a 12.6mm vicm5_12.6 implantable collamer lens of diopter -11.00 tore/broke before loading on 23/march/2023.There was no patient contact.The lens was not implanted.A replacement lens of the same parameters was implanted into the left eye (os) and the problem was resolved.The reporter indicated the cause of the event is unknown device evaluation: h3 - type of investigation code: 10- device evaluation: the lens was returned dry in a microcentrifuge vial with debris on product.Visual inspection found haptic torn/bent with debris throughout the lens.Additional data: h6- type of investigation code: 3331- device history record (dhr) review: based on the results of the investigation, all released devices from the associated work order(s), including the suspected device, have been manufactured within established process parameters; and there is no indication that the manufacturing and processing of the device contributed to the complaint issue.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 ; 6263037902
• MDR Report Key: 16942482
• Report Number: 2023826-2023-01859
• Device Sequence Number: 6915821
• Product Code: MTA
• UDI-Device Identifier: 00840311300624
• UDI-Public: 00840311300624
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: P030016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/19/2023

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: 10/31/2025
• Device Model Number: VICM5_12.6
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/04/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/19/2023
• Supplement Date Received by Manufacturer: 11/29/2023
• Initial Report FDA Received Date: 05/16/2023
• Supplement Report FDA Received Date: 12/04/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/28/2022
• 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: 30 YR
• Patient Sex: Female