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

Model Number	VTICM5_13.2
Medical Device Problem Codes	Misfocusing (1401); Inadequacy of Device Shape and/or Size (1583); Device Dislodged or Dislocated (2923); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Blurred Vision (2137); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/19/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
The reporter indicated the surgeon implanted a 13.2mm vticm5_13.2 implantable collamer lens, -11.00/+2.0/091 (sphere/cylinder/axis), into the patients left eye (os) on (b)(6) 2023.The lens was reported as low vaulting with lens rotation.The lens remained implanted.The cause of the event was unknown.Additional information has been requested but none has been forthcoming.
Additional Manufacturer Narrative
H6 - work order search: no similar complaint was reported for units within the same lot.Claim # (b)(4).
Additional Manufacturer Narrative
Additional data: b5: the reporter indicated that the surgeon implanted a 13.2mm vticm5_ 13.2 implantable collamer lens of diopter -11.0/+2.0/91 (sphere/cylinder/axis) into the patients left eye (os) on (b)(6) 2023.The patient experienced a refractive surprise.On (b)(6) 2023, the lens was repositioned.The lens remains implanted.The reporter indicated the cause of the event is unknown.H6: health effect - clinical code (e): "2137" should be added.H6: health effect - impact code (f): "2199" should be removed and "4628" should be added.H6: medical device problem code (a): "2993" and "1401" should be added.Claim#: (b)(4).
Additional Manufacturer Narrative
Additional data: b5.- the reporter indicated that the surgeon implanted a 13.2mm vticm5_ 13.2 implantable collamer lens of diopter -11.0/+2.0/91 (sphere/cylinder/axis) into the patients left eye (os) on (b)(6) 2023.The patient experienced a refractive surprise.On (b)(6) 2023 the lens was repositioned.On (b)(6) 2024 the lens was exchanged for the same model, longer length lens and the problem was resolved.The reporter indicated the cause of the event is unknown.H6.- health effect- impact code (f): "4629" should be added.H11.- manufacturer narrative: secondary surgical intervention to remove/replace/reposition the lens is identified in the labeling as a known potential adverse event following icl implantation.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 ; 6263037902
• MDR Report Key: 18700107
• Report Number: 2023826-2024-00488
• Device Sequence Number: 6143696
• Product Code: QCB
• UDI-Device Identifier: 00840311311767
• UDI-Public: 00840311311767
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: P030016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/19/2024

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: 01/31/2026
• Device Model Number: VTICM5_13.2
• 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: 01/19/2024
• Supplement Date Received by Manufacturer: 03/05/2024; 10/16/2024
• Initial Report FDA Received Date: 02/13/2024
• Supplement Report FDA Received Date: 03/15/2024; 10/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/08/2023
• 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 SFC45- LOT # UNK.; FOAM TIP PLUNGER MODEL FTP - LOT # UNK.; INJECTOR MODEL MSI-PF - LOT # UNK.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 32 YR
• Patient Sex: Female