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

Model Number VICMO12.6

Device Problems Break (1069); Device Operates Differently Than Expected (2913); Torn Material (3024)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Code Available (3191)

Event Date 07/28/2016

Event Type  Injury  

Manufacturer Narrative

This product is manufactured in the u.S.But not marketed in the u.S.Lens not returned.(b)(4).

Event Description

The reporter indicated the surgeon inserted a 12.6mm vicmo12.6 implantable collamer lens, -12.0 diopter, and the lens tore/broke during delivery into the eye.The lens was removed with no apparent injury.The lens was exchanged for another same model/diopter lens and the problem was resolved.The patient's post-op best-corrected visual acuity was 20/20.

Manufacturer Narrative

Implant date (b)(6) 2016; explant date (b)(6) 2016; exchange date (b)(6) 2016.(b)(4).

Manufacturer Narrative

Device evaluation: the lens was returned dry in case/vial; surgical residue was clear; visual inspection found haptic broken (b)(4).

Event Description

Implant date (b)(6) 2016, explant date (b)(6) 2016, exchange date (b)(6) 2016.

• Brand Name: ICL (IMPLANTABLE COLLAMER LENS)
• Type of Device: INTRAOCULAR LENS
• Manufacturer (Section D): STAAR SURGICAL COMPANY; 1911 walker avenue; monrovia CA 91016
• Manufacturer (Section G): STAAR SURGICAL COMPANY; 1911 walker avenue; monrovia CA 91016
• Manufacturer Contact: michelle andres ; 1911 walker avenue; monrovia, CA 91016 ; 6263037902
• MDR Report Key: 5985705
• MDR Text Key: 55872642
• Report Number: 2023826-2016-01353
• Device Sequence Number: 1
• Product Code: MTA
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: 08/30/2016

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?: Yes
• Device Operator: Physician
• Device Expiration Date: 11/30/2018
• Device Model Number: VICMO12.6
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/09/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/30/2016
• Initial Date FDA Received: 09/28/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 03/20/2017; 03/21/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/23/2015
• 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: 20 YR