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

Model Number VTICMO12.6

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

Patient Problem No Code Available (3191)

Event Date 09/05/2017

Event Type  Injury  

Manufacturer Narrative

This product is manufactured in the u.S.But not marketed in the u.S.(b)(4).Conclusion code: off-label use [anterior endothelium chamber depth < 3.0mm (2.89mm)].(b)(4).

Event Description

The reporter indicated that the surgeon implanted a 12.6mm vticmo12.6 implantable collamer lens, -17.0/+1.50/099 (sphere/cylinder/axis), into the patient's left eye (os) on (b)(6) 2017.On (b)(6) 2017 the lens was exchanged with a shorter lens due to excessive vault.The problem is resolved.

Manufacturer Narrative

Device evaluation: the lens was returned dry, in a micro centrifuge vial.There was residue/debris on product.Visual inspection found no visible damage to the lens and foreign material on lens surface (residue and debris on lens).(b)(4).

• Brand Name: IMPLANTABLE COLLAMER LENS (ICL)
• Type of Device: PHAKIC 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: cynthia thai ; 1911 walker avenue; monrovia, CA 91016 ; 6263037902
• MDR Report Key: 7156013
• MDR Text Key: 96109395
• Report Number: 2023826-2017-01969
• Device Sequence Number: 1
• Product Code: MTA
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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: 12/06/2017

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: 08/31/2019
• Device Model Number: VTICMO12.6
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/28/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/06/2017
• Initial Date FDA Received: 12/29/2017
• Supplement Dates Manufacturer Received: 03/21/2018
• Supplement Dates FDA Received: 04/04/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/20/2016
• 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: 25 YR