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

Model Number	VICM5_13.2
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/25/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H6 - work order search: another similar complaint was reported for units within the same lot.Claim #(b)(4).
Event or Problem Description
The reporter indicated a 13.2mm vicm5_13.2 implantable collamer lens, -06.00 diopter, tore/broke during loading and the damage was noted after opening the vial.There was no patient contact.The problem was resolved.The cause of the event was unknown.
Additional Manufacturer Narrative
Corrected data: d4: serial no: (b)(6).Claim # (b)(4).
Additional Manufacturer Narrative
Additional data: h3: device evaluation: the lens was returned in liquid, in a microcentrifuge vial.Visual inspection found no visible damage to the lens.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.Corrected data: d4: primary unique device identifier (udi) #: (b)(4)."udi related data quality updates only" h4: device manufacture date: 16-nov-2023.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: 19265030
• Report Number: 2023826-2024-02037
• Device Sequence Number: 6968089
• Product Code: MTA
• UDI-Device Identifier: 00840311300853
• UDI-Public: (01)00840311300853(11)231116(17)261031(21)S2243122
• 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): 04/10/2024

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 Model Number: VICM5_13.2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/10/2024
• Supplement Date Received by Manufacturer: 05/09/2024; 09/04/2024
• Initial Report FDA Received Date: 05/07/2024
• Supplement Report FDA Received Date: 06/02/2024; 09/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/16/2023
• 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 # 1654288; FOAM TIP PLUNGER MODEL FTP - LOT # 1654332; INJECTOR MODEL MSI-PF - LOT # 1584292
• Patient Age: 30 YR
• Patient Sex: Female