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)
Date of Event	11/23/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H6: work order search: no similar complaints within associated lots were found.Claim# (b)(4).
Event or Problem Description
The reporter indicated that a 13.2mm vicm513.2 implantable collamer lens of -11.5 diopter lens was intraoperatively implanted and removed from the patient's left eye (os) on (b)(6) 2023, due to a lens tear/break during injection/delivery.On (b)(6) 2023, a back up lens was implanted and the problem was resolved.Cause of the event was reported as the device.
Additional Manufacturer Narrative
Corrected data: h6- health effect - impact code: "2199" should be removed."4628" and "4629" should be added.B5- the reporter indicated that the surgeon implanted a 13.2mm vicm5_13.2 implantable collamer lens of diopter -11.5 into the patients left eye (os) on (b)(6) 2023.Reportedly the lens tore/broke during injection/delivery into the eye.There was patient contact but no patient injury.The lens was implanted and removed intraoperatively.On (b)(6) 2023 the lens was exchanged and repositioned and the problem was resolved.The status of the eye as "normal".The reporter indicated the cause of the event was the device.Claim# (b)(4).
Additional Manufacturer Narrative
Corrected data: h6- health effect - impact code: "4629" should be removed.B5- the reporter indicated that the surgeon implanted a 13.2mm vicm5_13.2 implantable collamer lens of diopter -11.5 into the patients left eye (os) on (b)(6) 2023.Reportedly the lens tore/broke during injection/delivery into the eye.There was patient contact but no patient injury.The lens was implanted and removed intraoperatively.On (b)(6) 2023 a lens of the same parameters was implanted and repositioned and the problem was resolved.The status of the eye as "normal".The reporter indicated the cause of the event was the device.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 ; 800 royal oaks dr. suite:210; monrovia, CA 91016 ; 6263037902
• MDR Report Key: 18611049
• Report Number: 2023826-2024-00351
• Device Sequence Number: 7508770
• Product Code: MTA
• UDI-Device Identifier: 00840311300969
• UDI-Public: 00840311300969
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• 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,Followup
• Report Date (Section B): 01/17/2024

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: 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: 01/17/2024
• Supplement Date Received by Manufacturer: 03/26/2024; 03/26/2024
• Initial Report FDA Received Date: 01/30/2024
• Supplement Report FDA Received Date: 03/26/2024; 03/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Patient Sex: Male