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

Model Number	VTICM512.6
Medical Device Problem Codes	Misfocusing (1401); Off-Label Use (1494); Adverse Event Without Identified Device or Use Problem (2993); Unintended Movement (3026)
Health Effect - Clinical Codes	Blurred Vision (2137); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	09/23/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
The reporter indicated that a 12.6mm vticm512.6 implantable collamer lens of -7.5/1.5/122 (sphere/cylinder/axis) lens tore during injection/delivery into the right eye (od) of a patient with pre-existing progressive myopia, on (b)(6) 2023.Lens dislocation/subluxation and double vision are observed.Cause of the event is unknown.Reportedly, "haptics cut." the problem is not resolved.
Additional Manufacturer Narrative
A4-a6: unk.H6: off-label: pre-existing myopia.Work order search: no similar complaints within associated lots were found.Claim# (b)(4).
Additional Manufacturer Narrative
B5 - the reporter indicated that the surgeon implanted a 12.6mm vticm5_12.6, -7.50/1.50/123 (sphere/cylinder/axis) implantable collamer lens into the patient's right eye (od) on (b)(6)2023.The lens had tore/broke during injection/delivery into the eye.There was lens dislocation and subluxation and double vision.On (b)(6) 2024 the lens was repositioned, also on this date the lens was explanted and replaced with a same length lens and the problem was resolved.The cause of the event was reported as unknown.H6 - health effect clinical code 4581 - double vision.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 91016
• Manufacturer (Section G): STAAR SUGICAL COMPANY; 1911 walker avenue; monrovia 91016
• Manufacturer Contact: joselene muniz ; 800 royal oaks dr. suite:210; monrovia, CA 91016 ; 6263037902
• MDR Report Key: 18080354
• Report Number: 2023826-2023-04850
• Device Sequence Number: 17789838
• Product Code: QCB
• UDI-Device Identifier: 00840311308057
• UDI-Public: 00840311308057
• Combination Product (Y/N): N
• Initial Reporter Country: IZ
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/25/2023

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: 06/30/2026
• Device Model Number: VTICM512.6
• 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: 10/25/2023
• Supplement Date Received by Manufacturer: 02/06/2024
• Initial Report FDA Received Date: 11/06/2023
• Supplement Report FDA Received Date: 02/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/19/2023
• 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; FOAM TIP PLUNGER - LOT# UNK; INJECTOR MODEL-MSI-TF, LOT#-UNK
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 28 YR
• Patient Sex: Male