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

Model Number	VTICM5_12.6
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/20/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A4 - unk.A5 - unk.A6 - unk.H6 - work order search: no similar complaint type events were reported for units within the same lot.Claim# (b)(4).
Event or Problem Description
The reporter indicated that a 12.6mm, vticm5 12.6, -10.0/1.0/111 (sphere/cylinder/axis), implantable collamer lens was implanted into the patient's right eye (od) on 14/aug/2023.Lens rotation not associated to a low vault was observed.The lens was repositioned on 23/oct/2023.This did not resolve the problem.Lens remains implanted.Additional information has been requested but none has been forthcoming.
Additional Manufacturer Narrative
Additional information: b5 - later an update was reported and the lens was explanted on 20-nov-2023 and replaced with a longer length lens.The problem was resolved.Day one postop of the patient 20/15 ar -1.25+1.75x067 40% vault.Claim#: (b)(4).
Additional Manufacturer Narrative
Corrected data: b5 - "-10.0/1.0/111" - should be corrected to -11.0/1.0/111.Cause of the event was reported as the device.Additional information: b5 - lens was explanted due to lens was received back by manufacturer.D7 - explant date unknown but lens was removed.H3 - device evaluation: the lens was returned in liquid in a microcentrifuge vial.Visual inspection found haptic torn.
Additional Manufacturer Narrative
H3 - device evaluation: the lens was returned in a vial in liquid.Visual inspection found haptic torn.Dimensional inspection found the lens to be within specifications.Claim # (b)(4).

• Brand Name: IMPLANTABLE COLLAMER LENS (ICL)
• Common Device Name: PHAKIC TORIC 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
• MDR Report Key: 18129707
• Report Number: 2023826-2023-04999
• Device Sequence Number: 12691678
• Product Code: QCB
• UDI-Device Identifier: 00841542115100
• UDI-Public: 00841542115100
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 10/24/2023

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: 12/31/2023
• Device Model Number: VTICM5_12.6
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• 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: 10/24/2023
• Supplement Date Received by Manufacturer: 12/20/2023; 01/16/2024; 03/04/2024
• Initial Report FDA Received Date: 11/14/2023
• Supplement Report FDA Received Date: 01/15/2024; 01/23/2024; 03/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/05/2022
• 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: INJECTOR MODEL#LIOLI-24,LOT#UNK.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 27 YR
• Patient Sex: Male