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

Model Number	VTICMO12.1
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	09/01/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H6: health impact- clinical code: 4581 - pigment dispersion, refractive change overtime.H6: health impact - additional surgery: 4625 - incision enlarged, suture.H6 - work order search: no similar complaint was reported for units within the same lot.Claim # (b)(4).
Event or Problem Description
The reporter indicated the surgeon implanted a 12.1mm vticmo12.1 implantable collamer lens, -18.00/+4.0/112 (sphere/cylinder/axis), into the patients right eye (od) on (b)(6) 2023.The lens was removed on ((b)(6) 2023 due to lens rotation (lens dislocation/subluxation), pigment dispersion and refractive change overtime.The incision was enlarged and a suture was required.The lens was replaced with a longer lens and the problem was resolved.Post-op, there was significant corneal edema and marked inflammation.See mfr.Report # 2023826-2023-04425 for replacement lens.The cause of the event was unknown.
Additional Manufacturer Narrative
H6: device history record (dhr) review: based on the results of the investigation, all released devices from the associated work order(s), including the suspected device; have been manufactured within established process parameters; and there is no indication that the manufacturing and processing of the device contributed to the complaint issue.(b)(4).
Additional Manufacturer Narrative
H3: device evaluation - lens was returned in microcentrifuge vial with moisture.Visual inspection found haptic torn.Dimensional inspection found the lens to be within specification.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 ; 6263037902
• MDR Report Key: 17894979
• Report Number: 2023826-2023-04389
• Device Sequence Number: 7119592
• Product Code: QCB
• UDI-Device Identifier: 00841542120289
• UDI-Public: 00841542120289
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P030016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/15/2023

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: 07/31/2024
• Device Model Number: VTICMO12.1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/15/2023
• Supplement Date Received by Manufacturer: 02/23/2024; 03/25/2024
• Initial Report FDA Received Date: 10/09/2023
• Supplement Report FDA Received Date: 03/14/2024; 03/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/07/2022
• 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 Age: 22 YR
• Patient Sex: Male