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

Model Number	TMICL13.2
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/16/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
The reporter indicated the surgeon implanted a 13.2mm tmicl13.2 implantable collamer lens, -11.50/+1.5/094 (sphere/cylinder/axis), in the patients right eye (od) on (b)(6) 2021.The lens was explanted on (b)(6) 2022 due to lens rotation not associated to a low vault.The lens was repositioned on (b)(6) 2021 but the problem was not resolved, so the lens was explanted.The lens was replaced with another same model/length lens and the problem was resolved.Post-op, the ucva was good but there was glare.The cause of the event was due to the device.The lens was discarded.
Additional Manufacturer Narrative
Work order search: no similar complaint was reported for units within the same lot.(b)(4).
Additional Manufacturer Narrative
Corrected data: b5- " the reporter indicated that the surgeon implanted a 13.2mm tmicl 13.2 implantable collamer lens of diopter-11.5/+1.5/094 (sphere/cylinder/axis) into the patient's right eye (od) on (b)(6) 2022.The patient experienced rotation not associated with a low vault.On (b)(6) 2021 the lens was rotated but this did not resolve the problem.On (b)(6) 2022 the lens was explanted and replaced with a lens of the same model/ length and the problem was resolved.The status of the eye was reported as "good ucva.C/o glare od (ticl) vs.Os (spherical)".The reporter indicated the cause of the event was the device and the device failed to perform as intended.The lens was discarded" 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 enriquez ; 1911 walker avenue; monrovia, CA 91016
• MDR Report Key: 14841733
• Report Number: 2023826-2022-01954
• Device Sequence Number: 19424892
• Product Code: QCB
• UDI-Device Identifier: 00841542109239
• UDI-Public: 00841542109239
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: P030016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/01/2022

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: 10/31/2022
• Device Model Number: TMICL13.2
• 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: 06/01/2022
• Supplement Date Received by Manufacturer: 10/19/2022
• Initial Report FDA Received Date: 06/28/2022
• Supplement Report FDA Received Date: 10/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/17/2020
• 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: UNK.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 31 YR
• Patient Sex: Male