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

Model Number	VTICM512.1
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/08/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D4 (experiation date); unk no serial number reported.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).Refractive surprise and lens rotation are observed.
Additional Manufacturer Narrative
Additional information: b5: the reporter indicated that a 12.1mm vticm512.1 implantable collamer lens of a -5.0/4.0/171 (sphere/cylinder/axis) was implanted into the patient's eye.H6: work order search: no similar complaints within associated lots were found.Claim# (b)(4).
Additional Manufacturer Narrative
Correction: d4: serial# (b)(6).H6: work order search was performed but was not required for previous entered lens# or corrected lens#.B5: the reporter indicated that a 12.1mm vticm512.1 implantable collamer lens of a -7.50/3.0/175 (sphere/cylinder/axis) was implanted into the right eye (od) of a patient with pre-existing keratoconus on (b)(6) 2024.On (b)(6) 2024, the lens was removed due to refractive surprise.In a subsequent surgery later that day, replacement lens was implanted and the problem was not resolved.It was reported that there was no improvement with continued high astigmatism.Cause of the event is unknown.Claim# (b)(4).
Additional Manufacturer Narrative
Additonal information: b5: a healthcare professional reported the patient's condition has improved to 20/20 after placing a suture.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 ; 800 royal oaks dr.suite:210; monrovia, CA 91016 ; 6263037902
• MDR Report Key: 18862537
• Report Number: 2023826-2024-00841
• Device Sequence Number: 7071696
• Product Code: QCB
• UDI-Device Identifier: 00840311305537
• UDI-Public: 00840311305537
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: P030016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• 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
• Report Date (Section B): 02/21/2024
• 2 Devices were Involved in the Event: 1 2

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: 06/30/2026
• Device Model Number: VTICM512.1
• 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: 02/21/2024
• Supplement Date Received by Manufacturer: Not provided; 04/25/2024; 07/03/2024
• Initial Report FDA Received Date: 03/07/2024
• Supplement Report FDA Received Date: 04/15/2024; 04/26/2024; 07/19/2024
• Date Device Manufactured: 08/10/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: CARTRIDGE MODEL: SFC-45 - LOT# UNK; FOAM TIP PLUNGER - LOT# UNK; INJECTOR MODEL: LIOLI-24 - LOT# UNK
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 37 YR
• Patient Sex: Female