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

Model Number	TMICL13.2
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Cataract (1766); Capsular Bag Tear (2639)
Date of Event	09/15/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The lens was returned in liquid in lens vial.Visual inspection found the haptics torn.(b)(4).No similar complaint was reported for units within the same lot.(b)(4).
Event or Problem Description
The reporter indicated the surgeon inserted and removed a 13.2mm tmicl13.2 implantable collamer lens, -13.00/+3.5/094 (sphere/cylinder/axis), during the same surgery, due to an anterior subcapsular opacity and a capsular tear had occurred.Cataract surgery was performed and an iol lens was implanted in the ciliary sulcus.The reporter indicated the cause of the event was due to 2 pits were noted in the lens capsule (anterior) directly below the iridotomies.When the lens was inserted a capsular tear extended from the pits.

• 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
• MDR Report Key: 10706991
• Report Number: 2023826-2020-02407
• Device Sequence Number: 19573244
• Product Code: QCB
• UDI-Device Identifier: 00841542109482
• UDI-Public: 00841542109482
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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: 2020
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/24/2020

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: 09/30/2021
• Device Model Number: TMICL13.2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/01/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/24/2020
• Initial Report FDA Received Date: 10/20/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 25 YR