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

Model Number	VICM513.2
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient weight, ethnicity and race: unk.(b)(4).
Event or Problem Description
The reporter indicated that an implantable collamer lens tore during loading at the point of injection.Reportedly, "the primary lens was not able to be used due to a loading error during our surgery today (fellow eye).The back up lens was used, and no adverse event happened in regard to patient health; we had a successful implantation using the back up lens.The rest of the surgery proceeded as normal." the problem was resolved.Cause of the event is unknown.It was reported, "per site malfunction occured while the device was loaded and was noted at the point of injection.".
Additional Manufacturer Narrative
Additional information: b5: the reporter indicated that a 13.2mm vicm513.2 of a -9.50 diopter tore during loading.H6: work order search: no similar complaints within associated lots were found.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 SUGICAL COMPANY; 1911 walker avenue; monrovia CA 91016
• Manufacturer Contact: joselene muniz ; 1911 walker avenue; monrovia, CA 91016 ; 6263037902
• MDR Report Key: 16457207
• Report Number: 2023826-2023-00518
• Device Sequence Number: 6572995
• Product Code: MTA
• UDI-Device Identifier: 00841542119405
• UDI-Public: 00841542119405
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2024
• Device Model Number: VICM513.2
• 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: 01/30/2023
• Supplement Date Received by Manufacturer: 06/05/2023
• Initial Report FDA Received Date: 02/28/2023
• Supplement Report FDA Received Date: 06/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/08/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: CARTRIDGE MODEL: SFC-45 - 1589912.; FOAM TIP PLUNGER - LOT# 1590136.; INJECTOR MODEL: MSI-TF - LOT# UNK.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown