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); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Blurred Vision (2137); No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A4-a6:unk.B3: unk.D4 (experiation date); unk no serial number reported.D6a: unk.H4 (device manufacturing date): no serial number reported.(b)(4).
Event or Problem Description
The reporter indicated that an implantable collamer lens was implanted into the patient's eye.Reportedly, "toric evo has rotated.".
Additional Manufacturer Narrative
B5: a 12.6mm vticm512.6 was implanted into the left eye (os) of a patient with pre-existing meibomian gland dysfunction.Lens rotation not associated to low vault was observed.Reportedly, "pt c/o blurred vison os." the problem has not resolved.H6: off-label - pre-existing meibomian gland dysfunction.Claim# (b)(4).
Additional Manufacturer Narrative
H6 - work order search: no additional similar complaint type event within associated lots was found.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 SUGICAL COMPANY; 1911 walker avenue; monrovia CA 91016
• Manufacturer Contact: joselene muniz ; 1911 walker avenue; monrovia, CA 91016 ; 6263037902
• MDR Report Key: 17322215
• Report Number: 2023826-2023-02772
• Device Sequence Number: 6365513
• Product Code: QCB
• UDI-Device Identifier: 00841542114455
• UDI-Public: 00841542114455
• 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
• 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): 06/27/2023
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2024
• Device Model Number: VTICM5_12.6
• 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: 06/27/2023
• Supplement Date Received by Manufacturer: 07/24/2023; 08/10/2023
• Initial Report FDA Received Date: 07/13/2023
• Supplement Report FDA Received Date: 08/08/2023; 08/10/2023
• Date Device Manufactured: 05/30/2022
• 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.
• Patient Sex: Female