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); Inadequacy of Device Shape and/or Size (1583); No Apparent Adverse Event (3189)
Health Effect - Clinical Codes	Blurred Vision (2137); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/31/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A4-a6:unk h6: work order search: no similar complaints within associated lots were found.Claim (b)(4).
Event or Problem Description
The reporter indicated that a 12.6mm vticm512.6 implantable collamer lens of -8.0/1.5/50 (sphere/cylinder/axis) was implanted into the patient's right eye (od) on (b)(6) 2023.Excessive vault and refractive surprise were observed.The problem is not resolved.
Additional Manufacturer Narrative
Health effect - clinical code: "2137" should be added.The reporter indicated the surgeon implanted a 12.6mm vticm5_12.6 implantable collamer lens of diopter -8.0/+1.5/050 (sphere/cylinder/axis) into the patients right eye (od) on (b)(6) 2023.The patient experienced excessive vault, refractive surprise and blurry vision.The lens remains implanted and the problem was not resolved.Reportedly "a new lens is ordered (different lens power) to correct the refractive surprise.The same lens size is used.I will visit the clinic on (b)(6) and will ask if they already exchanged the lens and how the outcomes are." claim# (b)(4).
Additional Manufacturer Narrative
It was later reported that on (b)(6) 2024 the lens was explanted.On (b)(6) 2024 a replacement lens of the same length and different axis and power was implanted and the problem was resolved.Claim#: (b)(4).
Additional Manufacturer Narrative
Additional information: b5 a facility representative reported that an implantable collamer lens was implanted into the patient's eye.The patient experienced refractive surprise and excessive vaulting.The lens was explanted and replaced with shorter length lens and different power.The problem was resolved.H3 device evaluation: lens was returned in a micro-centrifuge vial with moisture and residue/debris on the lens.Visual inspection found no visible damage to the lens.Dimensional and functional inspection found the lens to be within specifications.(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 SUGICAL COMPANY; 1911 walker avenue; monrovia CA 91016
• Manufacturer Contact: joselene muniz ; 800 royal oaks dr. suite 210; monrovia, CA 91016 ; 6263037902
• MDR Report Key: 18296806
• Report Number: 2023826-2023-05486
• Device Sequence Number: 7034890
• Product Code: QCB
• UDI-Device Identifier: 00840311308064
• UDI-Public: 00840311308064
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• 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,Followup,Followup
• Report Date (Section B): 11/28/2023

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: 05/31/2026
• Device Model Number: VTICM512.6
• 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: 11/28/2023
• Supplement Date Received by Manufacturer: 02/22/2024; 03/14/2024; 07/24/2024
• Initial Report FDA Received Date: 12/08/2023
• Supplement Report FDA Received Date: 02/23/2024; 04/08/2024; 09/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/06/2023
• 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: INJECTOR MODEL: MSI-PF - LOT# UNK.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 55 YR
• Patient Sex: Female