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

Model Number TMICL13.2

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Cataract (1766); Capsular Bag Tear (2639)

Event Date 09/15/2020

Event Type  Injury  

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 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)
• Type of Device: 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: cynthia thai ; 1911 walker avenue; monrovia, CA 91016 ; 6263037902
• MDR Report Key: 10706991
• MDR Text Key: 212310380
• Report Number: 2023826-2020-02407
• Device Sequence Number: 1
• Product Code: QCB
• UDI-Device Identifier: 00841542109482
• UDI-Public: 00841542109482
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030016
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 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
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/24/2020
• Initial Date FDA Received: 10/20/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/09/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 25 YR