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

Model Number	VTICM512.6
Medical Device Problem Codes	Misfocusing (1401); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Blurred Vision (2137)
Date of Event	09/11/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
The reporter indicated that a 12.6mm vticm512.6 implantable collamer lens of -13.0/2.0/103 (sphere/cylinder/axis) was implanted into the patient's left eye (os) on (b)(6) 2023.Lens rotation not associated to a low vault.Cause of the event is unknown.The device did not perform as intended.Reportedly,"os icl has rotated at 8 weeks post-op.Cause unknown." status of eye is stated, "decreased vision, burning sensation," and "patient had icl inserted on (b)(6) 2023.Surgery was routine, and icl was inserted into the sulcus at the target axis of 175 degrees (5 degree rotation).Vision was 6/6 (20/20) post op, including upon examination on (b)(6) 2023.On (b)(6) 2023 the patient presented to the clinic with blurred vision which had started that morning and was not present before going to be the night before.No pain was noted but patient mentioned the eye felt a burning sensation 4 days earlier, prior to vision change.No trauma was noted by the patient.Upon examination the icl had rotated to an axis of 70 degrees since the last post-op visit.".
Additional Manufacturer Narrative
A4-a6:unk.H6: work order search: no similar complaints within associated lots were found.Claim# (b)(4).
Additional Manufacturer Narrative
Additional information: b5: on (b)(6) 2023, the lens was repositioned.On (b)(6) 2024, blurry vision and lens rotation were reported.Problem not resolved.Potential exchange planned.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: 800 royal oaks dr. suite210; monrovia, CA 91016 ; 6263037902
• MDR Report Key: 17814901
• Report Number: 2023826-2023-04230
• Device Sequence Number: 2342439
• Product Code: QCB
• UDI-Device Identifier: 00840311308446
• UDI-Public: 00840311308446
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: P030016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/14/2023

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2026
• Device Model Number: VTICM512.6
• 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: 09/14/2023
• Supplement Date Received by Manufacturer: 01/30/2024
• Initial Report FDA Received Date: 09/25/2023
• Supplement Report FDA Received Date: 02/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/22/2023
• 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# 1633263.; FOAM TIP PLUNGER - LOT# 1646599.; INJECTOR MODEL: MSI-TF - LOT# 1548614.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 29 YR
• Patient Sex: Male