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

Model Number VICMO12.6

Device Problems Device Operates Differently Than Expected (2913); Appropriate Term/Code Not Available (3191)

Patient Problem Dizziness (2194)

Event Date 06/13/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

The reporter indicated that the surgeon implanted a 12.6 mm vicmo12.6 implantable collamer lens, -8.0 diopter in to the patient's right eye (od) on (b)(6) 2016.The lens was explanted on (b)(6) 2016 due to the patient experiencing dizziness.The patient's post-op best corrected visual acuity was 20/20.

Manufacturer Narrative

Device evaluation: lens was returned dry, in lens case/vial.Clear surgical residue/debris was present on the product.Visual inspection found optic torn/split and haptic torn/broken/bent deformed.Foreign material (unidentified spots) was present on the lens surface.Dimensional inspection found lens measurements within specifications.Work order search: no similar complaints were reported for units within the same lot.Conclusion: as per dfu for this lens model, implantation of this lens in an individual with an anterior endothelium chamber depth (acd) below 3.0mm is contraindicated.This patient had an acd of 2.93mm at the time of implantation.(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: 6031493
• MDR Text Key: 57550850
• Report Number: 2023826-2016-01444
• Device Sequence Number: 1
• Product Code: MTA
• Combination Product (y/n): N
• Reporter Country Code: KN
• 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: 09/27/2016

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: 10/31/2018
• Device Model Number: VICMO12.6
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/25/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/27/2016
• Initial Date FDA Received: 10/14/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/31/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/18/2015
• 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: 39 YR