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

Model Number	VTICM5_13.2
Medical Device Problem Codes	Device Dislodged or Dislocated (2923); Adverse Event Without Identified Device or Use Problem (2993)
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 the surgeon implanted an implantable collamer lens into the patient's left eye (os).It was indicated there was rotation without low vaulting.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: h6- health effect - impact code (f): "2199" should be removed and "4629" and "4628" should be added.H6- medical device problem code (a): "2993" should be added.H6- type of investigation code: 4110- lens work order search-no similar complaint event(s) within associated lots were found.B5- the reporter indicated the surgeon implanted a 12.6mm vticm5_12.6 implantable collamer lens of diopter -13.00/3.0/103 (sphere/cylinder/axis) into the patient's left eye (os) (b)(6) 2023.The patient experienced a lens rotation not associated with a low vault.On (b)(6) 2023 the lens was repositioned but that did not resolve the problem.On (b)(6) 2024 the lens was exchanged with a different model, longer length lens and the problem was resolved.The status of the eye was noted to be "all good, patient is happy".The reporter indicated the cause of the event is unknown.Claim# (b)(4).
Additional Manufacturer Narrative
Additional data: h3 - type of investigation code: 10- device evaluation: the lens was returned dry in a lens case.Visual inspection found optic deformed.Haptic bent/ stretched out.Dimensional inspection found the lens to be within specifications.Claim# (b)(4).

• Brand Name: IMPLANTABLE COLLAMER LENS (ICL)
• Common Device Name: PHAKIC INTRAOCULAR LENS
• Manufacturer (Section D): STAAR SURGICAL COMPANY; 1911 walker avenue; monrovia 91016
• Manufacturer (Section G): STAAR SUGICAL COMPANY; 1911 walker avenue; monrovia CA 91016
• Manufacturer Contact: joselene muniz ; 1911 walker avenue; monrovia, CA 91016
• MDR Report Key: 18761119
• Report Number: 2023826-2024-00792
• Device Sequence Number: 19948913
• Product Code: MTA
• UDI-Device Identifier: 00840311312368
• UDI-Public: 00840311312368
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/02/2024

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: 03/31/2026
• Device Model Number: VTICM5_13.2
• 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: 02/02/2024
• Supplement Date Received by Manufacturer: 02/28/2024; 10/02/2024
• Initial Report FDA Received Date: 02/22/2024
• Supplement Report FDA Received Date: 02/28/2024; 10/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/24/2023
• 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 Sex: Male