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

Model Number	TMICL 13.2
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Claim#: (b)(4).
Event or Problem Description
The reporter indicated that an implantable collamer lens was implanted into a patient's eye and there may have experienced lens rotation which may require a ticl repositioning.Lens remains implanted.Attempts to obtain additional information have not been successful.If additional information is received a supplemental medwatch report will be submitted.
Additional Manufacturer Narrative
Additional data: b5: the reporter indicated that a 13.2mm timcl13.2 implantable collamer lens of diopter -8.00/2.0/101 (sphere/cylinder/axis) was implanted into the patient's eye.The patient experienced lens rotation; repositioning and prk was performed.On (b)(6) 2022, the lens was repositioned but that did not resolve the problem.On (b)(6) 2022, prk was performed.Reportedly "prk for residual refractive error.P.O on (b)(6) 2023 od ucva 20/25".The lens remains implanted.H6: investigation type code: 4110- lens work order search-no similar complaint event(s) within associated lots were found.Claim#: (b)(4).
Additional Manufacturer Narrative
Corrected data: d4- model#: timcl13.2 should be corrected to tmicl13.2.B5- "timcl 13.2" should be corrected to "tmicl 13.2".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: 14246746
• Report Number: 2023826-2022-01383
• Device Sequence Number: 4421308
• Product Code: QCB
• UDI-Device Identifier: 00841542108751
• UDI-Public: 00841542108751
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/29/2022

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/31/2024
• Device Model Number: TMICL 13.2
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• 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: 03/29/2022
• Supplement Date Received by Manufacturer: 01/10/2023; 04/03/2023
• Initial Report FDA Received Date: 04/28/2022
• Supplement Report FDA Received Date: 01/18/2023; 04/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/18/2022
• 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 Sex: Female