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	02/17/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H6 - work order search: no similar complaint was reported for units within the same lot.Claim # (b)(4).
Event or Problem Description
The reporter indicated a 12.1mm vicm5_12.1 implantable collamer lens, -05.50 diopter, was stuck in cartridge or injection system.There was patient contact but no injury.The surgeon noted when the lens was removed out of the vial, what looked like a scratch on the lens.The surgeon decided to use the lens and it jammed.The cause of the event was unknown.
Additional Manufacturer Narrative
H6: cartridge lot number search: no similar complaint was reported for units within the same lot.H6: device history record (dhr) review: the dhr review indicated that the product has been manufactured within the established process parameters and that there is no indication that the manufacturing and/or processing of the device contributed to the complaint issue.Claim # (b)(4).
Additional Manufacturer Narrative
H3: device evaluation: the lens was returned dry, in microcentrifuge vial, with debris on product.Visual inspection found the optic torn, with a scratch and the haptic torn.There was debris on the lens.(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: 18914568
• Report Number: 2023826-2024-00999
• Device Sequence Number: 6769799
• Product Code: MTA
• UDI-Device Identifier: 00840311300181
• UDI-Public: 00840311300181
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/21/2024

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: VICM5_12.1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/08/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/21/2024
• Supplement Date Received by Manufacturer: 03/14/2024; 05/07/2024
• Initial Report FDA Received Date: 03/15/2024
• Supplement Report FDA Received Date: 04/12/2024; 05/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/09/2023
• 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 # 1660109; FOAM TIP PLUNGER MODEL FTP - LOT # 1710683; INJECTOR MODEL MSI-PF - LOT # 1628617
• Patient Age: 45 YR
• Patient Sex: Female