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

Model Number	TMICL13.2
Medical Device Problem Codes	Misfocusing (1401); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Blurred Vision (2137); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/22/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No similar complaint type events were reported for units within the same lot.Claim # (b)(4).
Event or Problem Description
It was reported that a 13.2mm, tmicl13.2, -13/2/90 (sphere/cylinder/axis), implantable collamer lens was implanted into the patients left eye (0s) on (b)(6) 2021.On (b)(6) 2021 lens repositioning was performed due to lens rotation (unknown whether vault was low), it was reported that repositioning resolved the problem.For status of the eye (sign/symptoms): "resolved" was reported.Per study investigator, the cause of this event was related to the device.For additional information the reporter stated "per medical monitor of note, lens power calculation recommended by staar was tmicl 13.7, -13.00/2.0/080.However, the doctor chose to go with the tmicl 13.2.".
Additional Manufacturer Narrative
B5- per updated information "as of (b)(6) 2021, lens rotated again and subject had increased cylinder to baseline (2.75 vs.Baseline 2.25).Sle: rotated icl @ 087 (83 degrees of rotation).Claim # (b)(4).
Additional Manufacturer Narrative
B5 - per updated email, problem is resolved.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: cynthia thai ; 1911 walker avenue; monrovia, CA 91016 ; 8002927902
• MDR Report Key: 11891166
• Report Number: 2023826-2021-01675
• Device Sequence Number: 3911054
• Product Code: QCB
• UDI-Device Identifier: 00841542109451
• UDI-Public: 00841542109451
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: P990013
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/26/2021

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: 09/20/2022
• Device Model Number: TMICL13.2
• 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: 04/26/2021
• Supplement Date Received by Manufacturer: 10/19/2021; 06/16/2023
• Initial Report FDA Received Date: 05/26/2021
• Supplement Report FDA Received Date: 03/08/2022; 07/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/20/2020
• 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 W/FTP, LOT# UNK.; CARTRIDGE MODEL: SFC-45 W/FTP, LOT# UNK.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 29 YR
• Patient Sex: Male