MAUDE Adverse Event Report: CIBA VISION JOHOR SDN, BHD. AIR OPTIX AQUA MULTIFOCAL; LENSES, SOFT CONTACT, DAILY WEAR

Lot Number ASKU

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Herpes (1898); Ulcer (2274)

Event Type  Injury  

Manufacturer Narrative

The lot number has not been provided, however two unique identifiers were reported for this patient (contact lens powers -1.75 med and -2.50 med); at the time of this report, it is not known which contact lens power is associated with the event.This report is being submitted to represent the contact lens power of -1.75 med reported; an additional report will be submitted under manufacturer¿s reference number (b)(4) to represent the -2.50 med power reported.The complaint sample has not returned for evaluation.Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.(b)(4).

Event Description

It was reported by an optician on (b)(6) 2017 that, having worn this type of contact lens for years, a consumer was diagnosed with an ulcer on (b)(6) 2016 and was also found out to have (b)(6) at a later stage.The consumer was reported to be wearing the same type of lens at the time of report.Further information received from the optician on (b)(6) 2017 stated that the diagnoses of ulcer and (b)(6) were provided by an ophthalmologist.Further information was received on (b)(6) 2017, it was reported that only the patients right eye (od) was affected.The "spot" (ulcer) was located on the peripheral at the nasal side and it also state that "injury always visible," indicative of scar.The prescribed medication was unspecified, as was the modality and duration of treatment.Additional information has been requested but not yet received.

• Brand Name: AIR OPTIX AQUA MULTIFOCAL
• Type of Device: LENSES, SOFT CONTACT, DAILY WEAR
• Manufacturer (Section D): CIBA VISION JOHOR SDN, BHD.; #1 dpb/5 tanjung pelepas port; gelang patah; johor darul takzim johor 81560 ; MY 81560
• Manufacturer (Section G): CIBA VISION JOHOR SDN, BHD.; #1 dpb/5 tanjung pelepas port; gelang patah; johor darul takzim johor 81560 ; MY 81560
• Manufacturer Contact: rita lopez ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8175514846
• MDR Report Key: 6527447
• MDR Text Key: 73896754
• Report Number: 3006186389-2017-00028
• Device Sequence Number: 1
• Product Code: LPL
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: K073459
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 04/27/2017

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: Lay User/Patient
• Device Lot Number: ASKU
• Other Device ID Number: ASKU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/31/2017
• Initial Date FDA Received: 04/27/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other