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

Model Number TMICL12.6

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

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Date of event-unk.(b)(4).

Event Description

The reporter indicated that the surgeon implanted a 12.6mm tmicl12.6 lens, -14.0/+4.0/093 (sphere/cylinder/axis) into the patient's left (os) eye on (b)(6) 2020.On (b)(6) 2020 the lens was exchanged with a shorter lens due to excessive vault.The problem is resolved.

Manufacturer Narrative

Claim# (b)(4).

Manufacturer Narrative

Corrected data: b5- the reporter indicated that the surgeon implanted a 12.6mm tmicl12.6 lens, -14.0/+4.0/093 (sphere/cylinder/axis) into the patient's right eye (od) eye on (b)(6) 2020.On (b)(6) 2020 the lens was exchanged with a shorter lens due to excessive vault.The problem is resolved.(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
• MDR Report Key: 10491989
• MDR Text Key: 205688943
• Report Number: 2023826-2020-01956
• Device Sequence Number: 1
• Product Code: QCB
• UDI-Device Identifier: 00841542107464
• UDI-Public: 00841542107464
• 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,Followup
• Report Date: 08/05/2020

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: TMICL12.6
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/05/2020
• Initial Date FDA Received: 09/03/2020
• Supplement Dates Manufacturer Received: 09/18/2020; 12/01/2020
• Supplement Dates FDA Received: 10/15/2020; 12/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention