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	08/01/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The reporter indicated the surgeon attempted to insert a 12.1mm vicm5_12.1 implantable collamer lens, -06.50 diopter.There was patient contact.The backup lens was implanted.Additional information has been requested but none has been forthcoming.
Additional Manufacturer Narrative
Lot # expiration date: 31-may-2024.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 that the surgeon attempted to implant a 12.1mm vicm5_12.1 implantable collamer lens of diopter -6.50 into the left eye (os) when the lens tore/broke before/during loading on (b)(6) 2022.Reportedly there was patient contact and the damage occurred during loading/after opening the vial.The lens was explanted and replaced with a back up lens of the same model/length lens and the problem was resolved.Reportedly the status of the eye is "damaged icl" and "noted upon implantation".The device failed to perform as intended.The cause details were reported as "stuck in cartridge".H3: device evaluation: the lens was returned in a vial with liquid.Visual inspection found no visible damage.Claim #(b)(4).
Additional Manufacturer Narrative
Corrected data: b5- "the reporter indicated that the surgeon attempted to implant a 12.1mm vicm5_12.1 implantable collamer lens of diopter -6.50 into the left eye (os) when the lens tore/broke before/during loading.Reportedly there was patient contact and the damage occurred during loading/after opening the vial.A back up lens of the same model/length was implanted intraoperatively and the problem was resolved.Reportedly the status of the eye is "damaged icl" and "noted upon implantation".The reporter indicated the device failed to perform as intended.The cause details were reported as "stuck in cartridge"." h6- health effect- impact code: 4627 should be removed.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 enriquez ; 1911 walker avenue; monrovia, CA 91016
• MDR Report Key: 15296595
• Report Number: 2023826-2022-02787
• Device Sequence Number: 11459786
• Product Code: MTA
• UDI-Device Identifier: 00841542118880
• UDI-Public: 00841542118880
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/04/2022

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 Model Number: VICM5_12.1
• 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: 08/04/2022
• Supplement Date Received by Manufacturer: 11/18/2022; 11/28/2022
• Initial Report FDA Received Date: 08/25/2022
• Supplement Report FDA Received Date: 11/21/2022; 11/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/30/2022
• 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: UNK.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 37 YR
• Patient Sex: Female