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

Model Number TMICL13.2

Device Problem Inadequacy of Device Shape and/or Size (1583)

Patient Problem No Code Available (3191)

Event Date 10/22/2018

Event Type  Injury  

Manufacturer Narrative

Device evaluation: the lens was returned in liquid, in the lens vial.Visual inspection found no visible damage to the lens.(b)(4).

Event Description

The reporter indicated that the surgeon implanted a 13.2mm tmicl13.2 lens, -6.5/+1.0/105 (sphere/cylinder/axis) into the patient's left (os) eye on (b)(6) 2018.On (b)(6) 2018 the lens was exchanged for a shorter lens due to over vaulting.The problem was resolved."no patient injury" is reported.

Manufacturer Narrative

Claim#: (b)(4).

• 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
• MDR Report Key: 8090050
• MDR Text Key: 127907253
• Report Number: 2023826-2018-01694
• Device Sequence Number: 1
• Product Code: QCB
• UDI-Device Identifier: 00841542108522
• UDI-Public: 00841542108522
• Combination Product (y/n): N
• PMA/PMN Number: P030016
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 10/25/2018
• 2 Devices were Involved in the Event: 1 2

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: 09/30/2020
• Device Model Number: TMICL13.2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/14/2018
• Initial Date Manufacturer Received: 10/25/2018
• Initial Date FDA Received: 11/20/2018
• Supplement Dates Manufacturer Received: 03/14/2019
• Supplement Dates FDA Received: 03/14/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 41 YR