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); Off-Label Use (1494)
Health Effect - Clinical Code	Blurred Vision (2137)
Date of Event	07/18/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A4 - unk.A5 - unk.A6 - unk.H6 - work order search: no similar complaint type events were reported for units within the same lot.Claim#(b)(4).
Event or Problem Description
The reporter indicated that a 12.6mm, vticm5_12.6, -9.50/2.5/092 (sphere/cylinder/axis), implantable collamer lens was implanted into the patient's left eye (os) on (b)(6) 2023.On (b)(6) 2023 the lens was explanted due to refractive surprise.A same size , different power (sphere/cylinder/axis) lens was implanted on (b)(6) 2023 to resolve the problem.
Additional Manufacturer Narrative
Device evaluation: h3 - type of investigation code: 10- device evaluation: the lens was returned in a microcentrifuge vial with liquid.Visual inspection found haptic torn.Lens model size returned is not lens model size stated in claim.Dimensional inspection found the overall width within specifications but overall length found the returned lens did not meet original values measured at the time of manufacturing.Functional inspection found the returned lens did not meet original values measured at the time of manufacturing.Claim# (b)(4).
Additional Manufacturer Narrative
Additonal data: h6- type of investigation code: 3331- device history record (dhr) review: the dhr review indicates that the product has not been manufactured within the established process parameters and that there is indication that the manufacturing and/or processing of the device contributed to the complaint issue.Root cause was not determined.Corrected data: b5-the reporter indicated that the surgeon horizontally implanted a 12.6mm vticm5_12.6 implantable collamer lens of diopter -9.50/2.5/092 (sphere/cylinder/axis) into the patient's left eye (os) on (b)(6) 2023.The patient experienced a refractive surprise.On (b)(6) 2023 the lens was repositioned.On (b)(6) 2023 the lens was exchanged with the same model, length and power and the problem was resolved.Reportedly "the surgeon suspected the lens(sn : (b)(6)) was mislabeled.Finally, he replaced it with a new one with the same size and power." h6- health effect- impact code: "4627" should be removed and "4628" should be added.H6 - medical device problem code 1494: off-label use (under 21 yrs of age at date of implantation) should be added.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: 17595281
• Report Number: 2023826-2023-03531
• Device Sequence Number: 7420329
• Product Code: QCB
• UDI-Device Identifier: 00840311308651
• UDI-Public: 00840311308651
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/03/2023

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: 03/31/2026
• Device Model Number: VTICM5_12.6
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/14/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/03/2023
• Supplement Date Received by Manufacturer: 09/25/2023; 01/26/2024
• Initial Report FDA Received Date: 08/22/2023
• Supplement Report FDA Received Date: 10/11/2023; 01/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/26/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 18 YR
• Patient Sex: Female