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

Model Number	TMICL 12.1
Medical Device Problem Code	Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Code	Cataract (1766)
Date of Event	11/03/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
The reporter indicated that a 12.1mm tmicl 12.1 implantable collamer lens of -13.5/1.5/105 (sphere/cylinder/axis) was implanted into the patients right eye (od) on (b)(6) 2021.Low vault with lens opacity (cataract) asc was reported.The lens was removed on (b)(6) 2022 and on the same day but different surgery a replacement lens of different model and longer length was implanted and the problem was not resolved.Cause reported as device; user error and unknown.The device failed to perform as intended."excessive low icl vault most likely contributed to lens opacity formation." see mfr # 2023826-2022-04656 for exchange lens.
Additional Manufacturer Narrative
Additional information: b5-the reporter indicated that a 12.1mm tmicl 12.1 implantable collamer lens of -13.5/1.5/105 (sphere/cylinder/axis) was implanted into the patients right eye (od) on (b)(6) 2021.Low vault with lens opacity (cataract) asc was reported.The lens was removed on (b)(6) 2022 and on the same day but different surgery a replacement lens of different model and longer length was implanted.Reportedly the exchange lens 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 SURGICAL COMPANY; 1911 walker avenue; monrovia CA 91016
• Manufacturer Contact: joselene enriquez ; 1911 walker avenue; monrovia, CA 91016
• MDR Report Key: 16018250
• Report Number: 2023826-2022-04428
• Device Sequence Number: 6678952
• Product Code: QCB
• UDI-Device Identifier: 00841542105170
• UDI-Public: 00841542105170
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P030016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2022
• 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
• Report Date (Section B): 11/21/2022

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: 09/30/2022
• Device Model Number: TMICL 12.1
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• 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: 11/21/2022
• Supplement Date Received by Manufacturer: 01/17/2023
• Initial Report FDA Received Date: 12/20/2022
• Supplement Report FDA Received Date: 01/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/24/2020
• 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: LOT# UNK; FOAM TIP PLUNGER (FTP), LOT# UNK
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 38 YR
• Patient Sex: Female