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

Model Number VTICMO12.6

Device Problems Break (1069); Device Operates Differently Than Expected (2913); Torn Material (3024)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Code Available (3191)

Event Date 03/29/2016

Event Type  Injury  

Manufacturer Narrative

This product is manufactured in the u.S.But not marketed in the u.S.Device evaluated by manufacturer? no - lens not returned.(b)(4).

Event Description

The reporter indicated the surgeon inserted a 12.6mm vticmo12.6 implantable collamer lens, -11.50/+2.0/060 diopter, in the patient's left eye (os) and the lens tore/broke during injection.The lens was removed with no apparent injury.The lens was exchanged for another same model but different diopter lens on (b)(6) 2016 and the problem was resolved.

Manufacturer Narrative

Product evaluation: the lens was returned dry in lens case/vial.Visual inspection found haptic torn/broken/bent/deformed and foreign material on lens surface.(b)(4): secondary surgical intervention, lens exchange.Conclusion: per dfu for this lens model, vticls are contraindicated for patients over the age of 45 years old and with an anterior chamber depth (acd), as measured from the corneal endothelium to the anterior lens capsure, less than 3.0mm.The patient was (b)(6) and had an acd of 2.80mm at the time of implantation.(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: 5668559
• MDR Text Key: 45572066
• Report Number: 2023826-2016-00632
• Device Sequence Number: 1
• Product Code: MTA
• Combination Product (y/n): N
• Reporter Country Code: IT
• 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: 04/19/2016

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?: Yes
• Device Operator: Physician
• Device Expiration Date: 11/30/2018
• Device Model Number: VTICMO12.6
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/26/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/19/2016
• Initial Date FDA Received: 05/19/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/13/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/23/2015
• 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: 48 YR