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

Model Number	VTICM5_13.2
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/11/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
The reporter indicated that a 13.2mm, vticm5_13.2, -8.5/1.5/089 (sphere/cylinder/axis), implantable collamer lens was implanted into the patient's right eye (od) on (b)(6) 2023.Lens rotation not associated to a low vault was observed.The lens was repositioned but did not resolve the problem.On (b)(6) 2023 the lens was exchanged for a longer length lens, this resolved the problem.Cause of the event is reported as device: lens too small than required.
Additional Manufacturer Narrative
H6 - work order search: no similar complaint type events were reported for units within the same lot.Claim#: (b)(4).
Additional Manufacturer Narrative
Lens was repositioned on (b)(6) 2023 but did not resolved the problem.Claim# (b)(4).
Additional Manufacturer Narrative
H3: device evaluation - lens was returned in microcentrifuge vial extremely dry.Visual inspection found haptic bent.Dimensional inspection found the lens to be within specification.Claim# (b)(4).
Additional Manufacturer Narrative
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: 18075209
• Report Number: 2023826-2023-04926
• Device Sequence Number: 7665824
• Product Code: QCB
• UDI-Device Identifier: 00840311311439
• UDI-Public: 00840311311439
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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,Followup
• Report Date (Section B): 10/20/2023

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 05/31/2026
• Device Model Number: VTICM5_13.2
• 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: 10/20/2023
• Supplement Date Received by Manufacturer: 11/17/2023; 06/14/2024; 09/30/2024
• Initial Report FDA Received Date: 11/06/2023
• Supplement Report FDA Received Date: 12/15/2023; 07/10/2024; 09/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/03/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: CARTRIDGE MODEL#SFC-45,LOT#UNK.; FOAMTIPPLUNGER MODEL#FTP,LOT#UNK.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 23 YR
• Patient Sex: Male