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

Model Number	VTICM5_12.6
Medical Device Problem Codes	Misfocusing (1401); Inadequacy of Device Shape and/or Size (1583); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Blurred Vision (2137)
Date of Event	07/31/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H6 - type of investigation - lens work order search: no similar complaint type events reported for units within the same lot.Claim# (b)(4).
Event or Problem Description
The reporter indicated that a 12.6mm vticm5_12.6 implantable collamer lens of -11.0/2.0/092 (sphere/cylinder/axis) was implanted into the patient's left eye (os) on (b)(6) 2023.The reporter reports excessive vault and states that there is still residual astigmatism, lens remains implanted.If additional information is received a supplemental medwatch report will be submitted.
Additional Manufacturer Narrative
Corrected data: b5- the reporter indicated the surgeon implanted a 12.6mm vticm5_12.6 implantable collamer lens of diopter -11.0/+2.0/92 (sphere/cylinder/axis) into the left eye (os) (b)(6) 2023.The patient experienced an excessive vault and refractive surprise.The lens remains implanted.Claim# (b)(4).
Additional Manufacturer Narrative
Additonal data: b5- the reporter indicated the surgeon implanted a 12.6mm vticm5_12.6 implantable collamer lens of diopter -11.0/+2.0/92 (sphere/cylinder/axis) into the left eye (os) (b)(6) 2023.The patient experienced an excessive vault and refractive surprise.On (b)(6) 2023 the lens was explanted.On the same day separate surgery the lens was replaced with the same model, shorter length lens and the problem was resolved.Additional information provided: "all well after exchange".The reporter indicated the cause of the event is unknown.H6- health effect- impact code: "2199" should be removed and "4627" should be added.H6- medical device code: "2993" should be added.Claim# (b)(4).
Additional Manufacturer Narrative
Device evaluation: h3 - type of investigation code: 10- device evaluation: the lens was returned in liquid in a vial.Visual inspection found no visible damage.Dimensional and functional 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 SUGICAL COMPANY; 1911 walker avenue; monrovia CA 91016
• Manufacturer Contact: joselene muniz ; 1911 walker avenue; monrovia, CA 91016 ; 6263037902
• MDR Report Key: 17814804
• Report Number: 2023826-2023-04277
• Device Sequence Number: 12279233
• Product Code: QCB
• UDI-Device Identifier: 00840311308408
• UDI-Public: 00840311308408
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• 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): 08/31/2023

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: 07/31/2025
• Device Model Number: VTICM5_12.6
• 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: 08/31/2023
• Supplement Date Received by Manufacturer: 12/06/2023; 03/20/2024; 08/14/2024
• Initial Report FDA Received Date: 09/25/2023
• Supplement Report FDA Received Date: 12/06/2023; 05/30/2024; 08/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/16/2022
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 36 YR
• Patient Sex: Female