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

Model Number VTICMO 12.1

Device Problems Fracture (1260); Device Operates Differently Than Expected (2913); Appropriate Term/Code Not Available (3191)

Patient Problems Visual Impairment (2138); Visual Disturbances (2140); Halo (2227)

Event Date 11/11/2015

Event Type  malfunction  

Manufacturer Narrative

This product is manufactured in the u.S.But not marketed in the u.S.Diopter: -9.50/+2.50/x099.Device evaluated by manufacturer? no, device remains implanted.(b)(4).Method code(s): evaluation method: lens work order search.Results code(s): evaluation results: a lens work order search revealed there were no similar complaints within the work order.Conclusions code(s): conclusion not yet available.Evaluation is in progress.(b)(4).Device remains implanted.

Event Description

The reporter indicated the surgeon implanted a 12.1mm vticmo12.1, -9.50/+2.5/x099 diopter implantable collamer lens in the patient's right eye (od) on (b)(6) 2015.The lens tore during insertion into the eye.A significant tear was noticed after implant.Lens was left in the eye with subsequent symptoms (halos and occasional diplopia) and displacement (lens rotation).Patient last office visit on (b)(6) 2015, ucva, 20/50.

Manufacturer Narrative

(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: althea watson ; 1911 walker avenue; monrovia, CA 91016 ; 6263037902
• MDR Report Key: 5365600
• MDR Text Key: 35921581
• Report Number: 2023826-2016-00009
• Device Sequence Number: 1
• Product Code: MTA
• Combination Product (y/n): N
• Reporter Country Code: MX
• 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: 12/15/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 02/28/2018
• Device Model Number: VTICMO 12.1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/15/2015
• Initial Date FDA Received: 01/13/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/22/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/31/2015
• 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
• Treatment: CARTRIDGE MODEL AND LOT NUMBER - UNK
• Patient Age: 23 YR