MAUDE Adverse Event Report: ABBOTT MEDICAL OPTICS ALLERGAN CUP (GORTEX); ACCESSORIES

Model Number AGNCG

Device Problems Crack (1135); Leak/Splash (1354)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/05/2015

Event Type  malfunction  

Manufacturer Narrative

Age/date of birth: unknown, not provided.Lot number: unknown, not provided.Expiration date: na (not applicable).Device manufacture date: unknown.All pertinent information available to abbott medical optics has been submitted.

Event Description

It was reported by a female patient who reported using the consept onestep lens case and it was cracked and solution leaked.The user destroyed the cracked lens case.The patient further reported that the same event occurred for two (2) other lens cases and she noticed cracks after about one-month of use for both cases.The patient reports three (3) lens case events, and therefore, three (3) mdrs will be filed.This report represents the first event, no lot number is known/provided.

Manufacturer Narrative

The initial mdr did not include the alternative report identification number: alternative report identification number: (b)(4).All pertinent information available to abbott medical optics has been submitted.

• Brand Name: ALLERGAN CUP (GORTEX)
• Type of Device: ACCESSORIES
• Manufacturer (Section D): ABBOTT MEDICAL OPTICS; santa ana CA
• Manufacturer (Section G): ABBOTT MEDICAL OPTICS INC.; 4th ave; hz econ/tech develop. zone; hangzhou 31001 8; CN 310018
• Manufacturer Contact: cathey ozuna ; 1700 east st. andrew place; santa ana, CA 92705 ; 7142478372
• MDR Report Key: 5390067
• MDR Text Key: 36805122
• Report Number: 3004178847-2016-00004
• Device Sequence Number: 1
• Product Code: LPN
• Combination Product (y/n): N
• PMA/PMN Number: P850088
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign
• Type of Report: Initial,Followup
• Report Date: 05/27/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/26/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: AGNCG
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/28/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1