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

Model Number VTICH12.6

Device Problems Off-Label Use (1494); Inadequacy of Device Shape and/or Size (1583); Appropriate Term/Code Not Available (3191)

Patient Problems Corneal Edema (1791); No Information (3190); No Code Available (3191)

Event Date 09/30/2015

Event Type  Injury  

Manufacturer Narrative

This product was manufactured in (b)(6) and is not marketed in the u.S.Device evaluated by manufacturer? no.Lens implanted.(b)(4).

Event Description

The reporter indicated the surgeon implanted a 12.6mm vtich12.6 implantable collamer lens, +1.50/0.5/x090 diopter, in the patient's right eye (od) on (b)(6) 2012.The reporter indicated the lens had an excessive vault and the surgeon is planning on explanting and exchanging the lens for a shorter lens.The lens remains implanted.

Manufacturer Narrative

Previously stated that the lens remains implanted.Updated/additional information: on (b)(4) 2015 the lens was exchanged with a shorter lens and the problem is resolved.Patient also experienced anterior bulging of the iris with angle narrowing and intermittent corneal edema.The lens was implanted piggyback with an miol.Additional information received in 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.' the cause of the event is reported as unknown, however the lens size was calculated using an acd of 3.2mm regardless of the actual acd value.Added report source.Device evaluation: the lens was returned dry in a lens case/vial.There was clear surgical residue/debris on the lens surface.Visual inspection found that the haptic was torn/broken/bent/deformed.(b)(4).

Manufacturer Narrative

Additional information: per updated information, the lens was implanted on (b)(6) 2015.The lens was exchanged on (b)(6) 2016.Work order search: no additional similar complaint type events found within associated lots.Corrected data: corrected to qcb in initial mdr.Corrected to 07-aug-2012.Claim# (b)(4).

• Brand Name: ICL (IMPLANTABLE COLLAMER LENS)
• Type of Device: INTRAOCULAR LENS
• Manufacturer (Section D): STAAR SURGICAL COMPANY AG; hauptstrasse 104; ch-2560, nidau ; SZ
• Manufacturer (Section G): STAAR SURGICAL COMPANY AG; hauptstrasse 104; ch-2560, nidau ; SZ
• Manufacturer Contact: cynthia thai ; 1911 walker avenue; monrovia, CA 91016 ; 6263037902
• MDR Report Key: 5193768
• MDR Text Key: 30012669
• Report Number: 2023826-2015-01441
• Device Sequence Number: 1
• Product Code: QCB
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 10/02/2015

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: Physician
• Device Expiration Date: 07/31/2015
• Device Model Number: VTICH12.6
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/10/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/02/2015
• Initial Date FDA Received: 11/01/2015
• Supplement Dates Manufacturer Received: 02/01/2016; 10/18/2019
• Supplement Dates FDA Received: 09/25/2019; 11/15/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/07/2012
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 52 YR