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

Model Number	VTICM5_12.6
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
Event or Problem Description
The reporter indicated that the surgeon implanted a 12.6mm vticm5_12.6, -10.50/1.5/093 (sphere/cylinder/axis), implantable collamer lens into the patient's right eye (od).The lens was replaced with a longer length lens due to lens rotation on (b)(6) 2023.Additional information has been requested but none has been forthcoming.
Additional Manufacturer Narrative
A2 - unk, a3 - unk, a4 - unk, a5 - unk, a6 - unk, b3 - unk, d6a - unk.H6 - work order search: no similar complaint(s) were reported for units within the same lot.Claim# (b)(4).
Additional Manufacturer Narrative
D6a - unk there was no confirmation that lens was explanted/exchanged on (b)(6) 2023.H6 - health effect - impact code: removed from inital mdr claim # (b)(4).
Additional Manufacturer Narrative
B5: the reporter indicated that the surgeon implanted a 12.6mm vticm5_12.6, -10.50/1.5/093 (sphere/cylinder/axis), implantable collamer lens into the patient's right eye (od).Lens rotation was observed.It is unknown if the lens remains implanted.There was no confirmation that lens was explanted/exchanged on (b)(6) 2023.Additional information has been requested but none has been forthcoming.H3: device evaluation: the lens was returned in liquid in a vial.Visual inspection found no visible damage to the lens.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: 17633313
• Report Number: 2023826-2023-03537
• Device Sequence Number: 17760703
• Product Code: QCB
• UDI-Device Identifier: 00841542115049
• UDI-Public: 00841542115049
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P030016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/08/2023

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: 03/31/2024
• 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
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/08/2023
• Supplement Date Received by Manufacturer: 10/19/2023; 10/19/2023
• Initial Report FDA Received Date: 08/28/2023
• Supplement Report FDA Received Date: 10/25/2023; 10/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/02/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: UNK.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown