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

Model Number VTICMO13.2

Device Problems Inadequacy of Device Shape and/or Size (1583); Appropriate Term/Code Not Available (3191)

Patient Problems No Code Available (3191); Missing Value Reason (3192)

Event Date 01/13/2016

Event Type  Injury  

Manufacturer Narrative

Diopter: -011.50/+2.00/x113.(b)(4).Method: lens work order search.Results: a lens work order search revealed there were no similar complaints within the work order.Conclusions: conclusion not yet available.Evaluation is in progress.(b)(4).

Event Description

The reporter indicated the surgeon implanted a 13.2mm vticmo13.2 -11.50/2.00/x113 diopter implantable collamer lens in patient's right eye on (b)(6) 2015.Excessive vaulting with significant reduction of indo-corneal angles was noted (b)(6) 2016.The lens was explanted and exchanged for a shorter lens.This resolved the problem.Ac is quiet and deep now.

Manufacturer Narrative

The lens was returned dry in the case/vial; surgical residue was cleared; visual inspection found haptic torn.(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: 5549244
• MDR Text Key: 41936715
• Report Number: 2023826-2016-00393
• Device Sequence Number: 1
• Product Code: MTA
• Combination Product (y/n): N
• Reporter Country Code: IN
• 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: 03/11/2016

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: 08/31/2018
• Device Model Number: VTICMO13.2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/03/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/08/2016
• Initial Date FDA Received: 04/05/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/10/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/15/2015
• 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: 24 YR