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

Model Number	VTICM513.2
Medical Device Problem Codes	Misfocusing (1401); Device Dislodged or Dislocated (2923); No Apparent Adverse Event (3189)
Health Effect - Clinical Code	Blurred Vision (2137)
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.Claim# (b)(4).
Event or Problem Description
The reporter indicated that an implantable collamer lens was implanted into the patient's right eye (od).A small refractive error was observed.Reportedly, "the toric icl remains in place and the patient does not want to do anything as she is so much better than she was before surgery.".
Additional Manufacturer Narrative
Claim# (b)(4).
Additional Manufacturer Narrative
B5: a 13.2mm vticm513.2 implantable collamer lens of a -10.0/2.5/093 (sphere/cylinder/axis) was implanted into the patient's eye.Claim# (b)(4).
Additional Manufacturer Narrative
H6: work order search: no similar complaints within associated lots were found.Claim# (b)(4).
Additional Manufacturer Narrative
Corrected data: b5- the reporter indicated that the surgeon implanted a 13.2mm vticm5_13.2 implantable collamer lens of diopter -10.00/2.5/093 (sphere/cylinder/axis) into the patient's right eye (od).The patient experienced a refractive surprise and lens rotation.The lens remains implanted.Reportedly "the patient has decided she does not need anything done and is happy with the outcome" h6- medical device problem code: "2923" should be added.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: 17599751
• Report Number: 2023826-2023-03624
• Device Sequence Number: 14531131
• Product Code: QCB
• UDI-Device Identifier: 00841542116602
• UDI-Public: 00841542116602
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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,Followup,Followup
• Report Date (Section B): 08/06/2023
• 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: 12/31/2023
• Device Model Number: VTICM513.2
• 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: 08/06/2023
• Supplement Date Received by Manufacturer: 09/25/2023; 09/25/2023; 09/25/2023; 01/10/2024
• Initial Report FDA Received Date: 08/22/2023
• Supplement Report FDA Received Date: 09/25/2023; 09/25/2023; 09/25/2023; 01/10/2024
• Date Device Manufactured: 04/02/2022
• 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
• Patient Sex: Unknown