MAUDE Adverse Event Report: CIBA VISION JOHOR SDN, BHD. AIR OPTIX PLUS HYDRAGLYDE; EXTENDED WEAR SOFT CONTACT LENS

Catalog Number CBVUNK00148

Device Problems Improper or Incorrect Procedure or Method (2017); Appropriate Term/Code Not Available (3191)

Patient Problems Corneal Abrasion (1789); Corneal Scar (1793); Corneal Ulcer (1796); Headache (1880); Pain (1994); Loss of Vision (2139)

Event Type  Injury  

Manufacturer Narrative

Device evaluated by mfr: the complaint sample has not returned for evaluation; the lot number is unknown.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.The manufacturer internal reference number is: (b)(4).

Event Description

As initially reported by the consumer on 22/mar/2023.It was stated that on an unknown date, the consumer had scratch on black part of eye / corneal abrasion, ulcer in the right cornea and had to have a transplant because of blindness.She stated to be in so much pain and blind and unable to take this pain in these headaches.Outcome of the event was unknown.Additional information has been requested but not yet available.

Manufacturer Narrative

H.3., h.6.: the actual complaint product was not returned for evaluation.The device history record and sterilization record for this lot have been reviewed and found to be in compliance.There was no nonconformity or deviations during the manufacturing process which related to the nature of the complaint.The root cause could not be determined.A2,b6, b5,g6, h2, h6, h11.,: new information had been received and the additional information has been updated.The manufacturer internal reference number is:(b)(4).

Event Description

Note: additional follow-up information received on 03/apr/2023, the consumer¿s dob and age was reported, the suspect drug was recoded from freshlook unspecified contact lenses to air optix plus hydraglyde and the current status of the event outcome of the consumer recovered with persistent.On 14/apr/2023, the status of the event outcome of the consumer is resolved and the additional event was coded as central corneal scar and product user error.Complaint: the additional event received from the physician stating that the consumer severely experienced pain or discomfort, redness, anterior chamber reaction events and mucopurulent discharge.The consumer was diagnosed with a corneal ulcer and one large central infiltrate present in the consumer¿s eye involving central part 4-6mm with the size of 4.9x4.6mm, 50 percentage of the cornea was involved in that staining process and permanent scarring noted in the right eye and antibiotic, tropane alkaloid and anticholinergic medication and steroid medication treatment were provided to the consumer.The physician advised the to visit the optometrist for the corneal transplant and the consumer didn¿t not keep follow-up appointments and compliance with medication.It was found that the corneal ulcer was due to the over wear of the contact lens about 30days.Discussion: corneal opacity: a condition in which the cornea is opaque (not transparent).Includes corneal opacity, corneal scar, eye opacity.Many corneal opacities start as persistent, non-healing epithelial defects that opacify as a result of infection, inflammation, tissue breakdown, and/or scarring.Reduced vision is often related to corneal surface irregularity in addition to the opacity itself, which reduces light transmission to the retina.Non-infectious corneal opacification develops gradually and may become permanent.Corneal opacity affecting the central corneal (within 6 mm of visual axis) or any opacity which permanently decreases visual acuity by =2 snellen lines (or equivalent measure).Conclusion: regulatory assessment for reporting complete.With current information, this report meets criteria for reporting based on applicable medical device regulations.Dsivaraj.

• Brand Name: AIR OPTIX PLUS HYDRAGLYDE
• Type of Device: EXTENDED WEAR SOFT CONTACT LENS
• 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: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8007579780
• MDR Report Key: 16688581
• MDR Text Key: 312764365
• Report Number: 9681121-2023-00002
• Device Sequence Number: 1
• Product Code: LPM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P010019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 05/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/06/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: CBVUNK00148
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/03/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: CONTACT LENS
• Patient Outcome(s): Other
• Patient Age: 47 YR
• Patient Sex: Female