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

Model Number VTICMO12.6

Device Problems Inadequacy of Device Shape and/or Size (1583); Positioning Problem (3009); Appropriate Term/Code Not Available (3191)

Patient Problem No Code Available (3191)

Event Date 03/28/2016

Event Type  Injury  

Manufacturer Narrative

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

Event Description

The reporter indicated the surgeon implanted a 12.5mm vticmo12, -17.00/+2.00/x080 diopter implantable collamer lens in patient's left eye on (b)(6) 2015.Lens rotation not associated to a low vault.The lens rotated 70 degrees and was repositioned.The lens was explanted and exchanged for a longer length lens with a similar diopter on (b)(6) 2016.This resolved the problem.

Manufacturer Narrative

Device evaluation - the lens was returned dry in a lens case/vial.Visual inspection found no visible damage to lens and foreign material on lens surface (dry discolored material).(b)(4).Conclusion: as per dfu for this lens model, vticls are contraindicated for patients over the age 45 years old.Corrected data: "the reporter indicated the surgeon implanted a 12.6mm vticmo12.6 -17.00/+2.00/x080 diopter implantable collamer lens into the patient's left eye on (b)(6) 2015.The patient experienced lens rotation not associated to a low vault.The lens rotated 70 degrees and was repositioned.The lens was explanted and exchanged for a longer lens with a similar diopter on (b)(6) 2016.This resolved the problem." (b)(4).

• Brand Name: ICL (IMPLANTABLE COLLAMER LENS)
• 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: michelle andres ; 1911 walker avenue; monrovia, CA 91016 ; 6263037902
• MDR Report Key: 5652082
• MDR Text Key: 45091586
• Report Number: 2023826-2016-00652
• 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
• Report Date: 04/08/2016

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: 04/30/2018
• Device Model Number: VTICMO12.6
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/18/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/08/2016
• Initial Date FDA Received: 05/12/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/04/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/04/2015
• 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: 54 YR