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

Model Number	TMICL12.6
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/16/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
The reporter indicated that 12.6mm tmicl12.6 implantable collamer lens of a -10.5/1.5/076 (sphere/cylinder/axis) was implanted into the patient's right eye (od) on (b)(6) 2020.Low vault with very mild cataract was reported.A lens exchange is planned.If additional information is received a supplemental medwatch report will be submitted.
Additional Manufacturer Narrative
Work order search: no similar complaints within associated lots were found.Claim# (b)(4).
Additional Manufacturer Narrative
B5: the lens was later intraoperatively removed and replaced for a different model, longer length lens due to low vault with rotation and lens opacity/asc.Mild cataract is still observed after replacement surgery.The surgeon has elected to watch the eye until cataract becomes more significant.Patient is satisfied with his vision as of right now.Manufacturer narrative: secondary surgical intervention to remove and replace the lens are identified in the labeling as a known potential adverse event following icl implantation.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: joselene muniz ; 800 royal oaks dr. suite 210; monrovia, CA 91016 ; 6263037902
• MDR Report Key: 19323063
• Report Number: 2023826-2024-01970
• Device Sequence Number: 12677381
• Product Code: QCB
• UDI-Device Identifier: 00841542106924
• UDI-Public: 00841542106924
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: P030016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/23/2024

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/31/2022
• Device Model Number: TMICL12.6
• 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: 04/23/2024
• Supplement Date Received by Manufacturer: 08/15/2024
• Initial Report FDA Received Date: 05/15/2024
• Supplement Report FDA Received Date: 08/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/02/2020
• 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: CARTRDIGE MODEL: SFC-45 - LOT# UNK
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 34 YR
• Patient Sex: Male