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

Model Number VICMO12.1

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

Patient Problem No Code Available (3191)

Event Date 07/22/2016

Event Type  Injury  

Manufacturer Narrative

This product is manufactured in the u.S.But not marketed in the u.S.(b)(4).Secondary surgical intervention, lens exchanged for a lens of the same model and size (b)(4).Lens not returned.

Event Description

The reporter indicated that the surgeon inserted a 12.1mm vicmo12.1 implantable collamer lens, -11.50 diopter, in the patient's right eye on (b)(6) 2016.The lens was explanted on (b)(6) 2016 due to a lens tear/break during injection/delivery into the eye.The lens was exchanged for a lens of the same model and size, and the problem was resolved.

Manufacturer Narrative

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

• 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: 6241488
• MDR Text Key: 64483683
• Report Number: 2023826-2017-00047
• Device Sequence Number: 1
• Product Code: MTA
• Combination Product (y/n): N
• Reporter Country Code: KS
• 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
• Report Date: 12/20/2016

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?: No
• Device Operator: Physician
• Device Expiration Date: 11/30/2018
• Device Model Number: VICMO12.1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/23/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/20/2016
• Initial Date FDA Received: 01/11/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/15/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/02/2015
• 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: 33 YR