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

Model Number	VICM5 13.2
Medical Device Problem Code	Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Claim # (b)(4).
Event or Problem Description
The reporter indicated that a 13.2mm vicm5 13.2 implantable collamer lens of -9.0 diopter was implanted into the patients left eye (os) on (b)(6) 2022.On (b)(6) 2022 the lens was removed due to a high vault.A replacement lens was implanted of unknown model and size.If additional information is received a supplemental medwatch report will be submitted.
Additional Manufacturer Narrative
Additional information: d9-return date: 31-aug-2022.H3 - device evaluation: the lens was returned in liquid in a vial.Visual inspection found the optic and haptic torn.Dimensional inspection found the lens to be within device specifications.Claim # (b)(4).
Additional Manufacturer Narrative
Corrected data: b5: the reporter indicated that a 13.2mm vicm5 13.2 implantable collamer lens of -8.50 diopter was implanted into the patients right eye (od) on (b)(6) 2022.On (b)(6) 2022 the lens was explanted due to a high vault.A replacement lens was implanted of unknown model and size on an unknown date.Claim# (b)(4).
Additional Manufacturer Narrative
Corrected data: b5: the reporter indicated that a 13.2mm vicm5 13.2 implantable collamer lens of -9.00 diopter was implanted into the patients right eye (od) on (b)(6) 2022.On (b)(6) 2022 the lens was explanted due to a high vault.A replacement lens was implanted of unknown model and size on an unknown date.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 enriquez ; 1911 walker avenue; monrovia, CA 91016
• MDR Report Key: 15285196
• Report Number: 2023826-2022-02892
• Device Sequence Number: 2467351
• Product Code: MTA
• UDI-Device Identifier: 00841542119399
• UDI-Public: 00841542119399
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P030016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 06/29/2022

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2024
• 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: 06/29/2022
• Supplement Date Received by Manufacturer: 03/22/2023; 04/05/2023; 04/19/2023
• Initial Report FDA Received Date: 08/24/2022
• Supplement Report FDA Received Date: 03/31/2023; 04/18/2023; 05/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/02/2022
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown