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

Model Number	TMICL 12.1
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/10/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Claim# (b)(4).
Event or Problem Description
The reporter indicated that the surgeon implanted a 12.1mm tmicl12.1 -9.0/1.0/116 (sphere/cylinder/axis) implantable collamer lens into the patient's right eye (od) on (b)(6) 2024.Low vault with lens rotation and transient loss of bcva was observed.Lens exchanged on (b)(6) 2024 with longer length lens and problem was resolved.Status of eye was reported as "trace cells both eyes, adequate vault both eyes negative seidel.Patient has noted improved vision at 1 day follow up both eyes." cause of event was reported as unknown; "patient was supposed to have a 600 vault.She ended up have an extremely low vault post op.".

• 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: 19595587
• Report Number: 2023826-2024-02816
• Device Sequence Number: 19847918
• Product Code: QCB
• UDI-Device Identifier: 00840311304448
• UDI-Public: 00840311304448
• Combination Product (Y/N): N
• 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): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/04/2024

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 Model Number: TMICL 12.1
• 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: 06/04/2024
• Initial Report FDA Received Date: 06/24/2024
• Date Device Manufactured: 04/09/2024
• 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: LIOLI-24 WITH FOAM, 1710778; LIOLI-24, FCK3002
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 39 YR
• Patient Sex: Female