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 Date 07/30/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

The reporter indicated that a 12.6mm, tmicl12.6, -10.5/2.0/108 (sphere/cylinder/axis), implantable collamer lens, was implanted into the patients left eye (os) on (b)(6) 2020.On (b)(6) 2020 the lens was exchanged for longer length lens due to low vault.This exchange resolved the problem.

Manufacturer Narrative

H3- device evaluation: lens was returned dry with residue in a sterility pouch.Visual inspection found one of the haptics bent and residue on lens surface.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
• MDR Report Key: 10492096
• MDR Text Key: 206550348
• Report Number: 2023826-2020-02018
• Device Sequence Number: 1
• Product Code: QCB
• UDI-Device Identifier: 00841542106931
• UDI-Public: 00841542106931
• Combination Product (y/n): N
• PMA/PMN Number: P030016
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 08/04/2020

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: 11/30/2021
• Device Model Number: TMICL12.6
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/17/2020
• Initial Date Manufacturer Received: 08/04/2020
• Initial Date FDA Received: 09/03/2020
• Supplement Dates Manufacturer Received: 09/01/2020
• Supplement Dates FDA Received: 10/01/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 40 YR