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 Retinal Detachment (2047); No Code Available (3191)

Event Date 03/28/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

The reporter indicated the surgeon implanted a toric implantable collamer lens, in (b)(6) 2019.The reporter indicated there was a retinal detachment and the surgery was uneventful.The surgeon indicated the patient was a very high myopic, which was her risk factor.Additional information has been requested but none has been forthcoming.If additional information is received, a supplemental medwatch will be submitted.

Manufacturer Narrative

The reporter indicated a 13.2mm tmicl13.2 implantable collamer lens, -10.5/+1.0/169 (sphere/cylinder/axis) was implanted in the patients left eye (os) on 03/26/2019.The patient had a retinal detachment and the retina was repaired.A scleral buckle was placed, with 20% gas fill at that visit.The lens remains implanted and the cause of the event was patient related factor.The patient is doing well.Patient code: 3191 - secondary surgical intervention, retinal repair, scleral buckle in place.Work order search: no similar complaint was reported for units within the same lot.(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: 8586209
• MDR Text Key: 144265719
• Report Number: 2023826-2019-00734
• Device Sequence Number: 1
• Product Code: QCB
• 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: 04/08/2019

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: 09/30/2020
• Device Model Number: TMICL13.2
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/08/2019
• Initial Date FDA Received: 05/07/2019
• Supplement Dates Manufacturer Received: 05/21/2019
• Supplement Dates FDA Received: 05/23/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CARTRIDGE MODEL SFC-45 - LOT # UNK; FOAM TIP PLUNGER MODEL FTP - LOT # UNK; INJECTOR MODEL MSI-PF - LOT # UNK
• Patient Outcome(s): Required Intervention
• Patient Age: 27 YR