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.Expiration date: na (not applicable).The lens case was returned to the manufacturing site for investigation.The returned oxycup was visually inspected and one crack line was found in the body of the oxycup.Product did not meet specification of appearance.Through the manufacturing record review, neither similar non-conformance report nor non-conforming product was found during the oxycup assembly process.Considering the returned product has been used by customer for about one month prior to the reported issue, there is a potential possibility that the cracked oxycup was caused by incorrect customer use.A manufacturing record review was performed.The record for the assembly process was found to be acceptable, no similar defect (cracked oxycup) was found.There was no non-conforming material report, or process/material change associated with this lot.There was no non-conformance reported for this lot.Manufacturing history of oxycups in the previous 12 months was also reviewed, there were no similar issues reported.In conclusion, lot 14060101 was deemed acceptable for release.Conclusion: the reported event of a crack in the oxycup was confirmed; however, the root cause for the reported crack could not be confirmed.Unknown if it was related to use of the product.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 third event, a lot number was provided on the returned lens case.

Manufacturer Narrative

The initial mdr did not include the alternative report identification number: section g7: 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: 5390069
• MDR Text Key: 36805206
• Report Number: 3004178847-2016-00006
• 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: 14060101
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/09/2015
• Date Manufacturer Received: 04/28/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/26/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1