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

Model Number VTICH13.2

Device Problems Off-Label Use (1494); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Retinal Detachment (2047); Vitrectomy (2643); No Code Available (3191)

Event Date 02/15/2016

Event Type  Injury  

Manufacturer Narrative

The product is manufactured in the us, but not marketed in the us.(b)(4).

Event Description

The reporter indicated the surgeon implanted a 13.2mm vtich13.2 implantable collamer lens, +0.5/+1.0/074 (sphere/cylinder/axis) into the patient's right eye (od) on (b)(6) 2015.The surgeon reports retinal detachment.Retinal repair was performed, including pars plana vitrectomy with c3f8 gas tamponade and eye drops.The problem is resolved.Reportedly, the lens remains implanted.The cause of the event is reported as unknown.Information initially received via an article published in clinical ophthalmology entitled 'a prospective pilot study using a low power piggy-back toric implantable collamer lens to correct residual refractive error after multifocal iol implantation.'.

Manufacturer Narrative

Work order search: no similar complaints found within associated lots.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: 9120437
• MDR Text Key: 161960974
• Report Number: 2023826-2019-01742
• Device Sequence Number: 1
• Product Code: QCB
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Type of Report: Initial,Followup
• Report Date: 08/28/2019

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: 04/30/2018
• Device Model Number: VTICH13.2
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/28/2019
• Initial Date FDA Received: 09/25/2019
• Supplement Dates Manufacturer Received: 10/18/2019
• Supplement Dates FDA Received: 11/13/2019
• 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: 57 YR