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

Model Number	TMICL12.6
Medical Device Problem Codes	Misfocusing (1401); Inadequacy of Device Shape and/or Size (1583); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Blurred Vision (2137)
Date of Event	10/05/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Work order search: 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 12.6 mm, tmicl12.6, -9.00/3.00/067(sphere/cylinder/axis), implantable collamer lens was implanted into the patients left eye (os) on (b)(6) 2019.On (b)(6) 2020 lens repositioning was performed due to lens rotation (toric icl continued to rotate) and blurred vision.On (b)(6) 2021 the lens was exchanged for a longer length lens and the problem resolved.
Additional Manufacturer Narrative
H3 - device evaluation: lens was returned in a container, in a sterile pouch.Visual inspection found the lens haptic torn.Claim#: (b)(4).
Additional Manufacturer Narrative
B5 - it was reported that a 12.6mm tmicl12.6 -9.00/3.00/067 (sphere/cylinder/axis) implantable collamer lens was implanted into the patients left eye (os) on (b)(6) 2019.Lens size too small; blurred vision and lens rotation were reported.On (b)(6) 2020 lens repositioning was performed but did not resolve the problem.On (b)(6) 2021 the lens was explanted and later replaced with a longer length lens.This resolved the problem.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: 11823603
• Report Number: 2023826-2021-01441
• Device Sequence Number: 3832187
• Product Code: QCB
• UDI-Device Identifier: 00841542106740
• UDI-Public: 00841542106740
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: P990013
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2021
• 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): 04/13/2021

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: 09/30/2020
• Device Model Number: TMICL12.6
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/24/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 04/13/2021
• Supplement Date Received by Manufacturer: 06/01/2021; 01/04/2022
• Initial Report FDA Received Date: 05/13/2021
• Supplement Report FDA Received Date: 06/29/2021; 01/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/10/2018
• 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# 1513545.; INJECTOR MODEL: MSI-PF, LOT# 1493078.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 31 YR
• Patient Sex: Male