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

Model Number VTICMO12.1

Device Problem Inadequacy of Device Shape and/or Size (1583)

Patient Problem No Code Available (3191)

Event Date 11/04/2016

Event Type  Injury  

Manufacturer Narrative

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

Event Description

The reporter indicated that the surgeon implanted a 12.1 mm vticmo12.1 implantable collamer lens, -08.0/+6.0/092 diopter in the patient's right eye (od) on (b)(6) 2016.The lens was explanted on (b)(6) 2016 due to low vaulting.The lens was exchanged for a longer lens and the problem was resolved.

Manufacturer Narrative

The lens was explanted due to low vaulting and rotation.Device evaluation: product evaluation found that the lens was returned dry in the lens case/vial.Visual inspection found the lens haptic torn.Work order search: no similar complaints were reported for units within the same lot.(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: 6216085
• MDR Text Key: 63661991
• Report Number: 2023826-2016-01849
• Device Sequence Number: 1
• Product Code: MTA
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: N/A
• 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: 12/01/2016

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: 04/30/2017
• Device Model Number: VTICMO12.1
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/21/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/01/2016
• Initial Date FDA Received: 12/30/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/29/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/15/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 32 YR