MAUDE Adverse Event Report: ALCON RESEARCH, LLC AOSEPT PLUS/CLEAR CARE PLUS WITH HYDRAGLYDE CLEANING AND DISINFECTING SOLUTION; ACCESSORIES, SOFT LENS PRODUCTS

Catalog Number 0003630004

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

Patient Problem No Code Available (3191)

Event Date 01/08/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).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

As initially reported by a consumer¿s mother thru email on (b)(6) 2019, the consumer was diagnosed with acute painful bilateral corneal erosions, abrasions and conjunctival erythema dated (b)(6) 2019 with medical reports attached.This was believed to be the result of the consumer cleaning her biofinity coopervision contacts with novartis/alcon¿s aosept plus with hydraglyde.The appellant reported that the consumer had experienced severe impaired vision on both eyes and could see ¿rainbow/halos¿ around light sources, also she complained of swollen, red eyes with acute pain which she described as stinging and burning with severe discomfort and sensitivity to light.On the report, the consumer had been using peroxide-based solution for a couple of years and said to adhere to the safety precaution of the product used and she just had recently switched to aosept plus with hydraglyde.She also added, that the consumer also uses the product for soaking contact lenses to be neutralized for eight hours without any issue and just before the incident the consumer had kept her lenses in a container with neutralizer for one week before using the contact lenses.She initially just experienced haziness in vision in the afternoon and excessive tearing during the night.However, at around 3:00 in the morning the consumer woke up to swollen, red eyes with excruciating pain and impaired visual acuity opting them to rush the client to the emergency department.Received additional information on (b)(6) 2019 stating the medications used by the consumer: sodium hyaluronate and xanthan gum eye gel, trehalose (3%) and hyaluronic acid (0.15%) eye drops and dexpanthenol eye gel with unknown duration and frequency.Received additional information on (b)(6) 2019 stating the consumer¿s eye status is getting much better.No more discomfort, no burning and stinging sensations reported, and no more excessive tearing.Also, the consumer¿s father verbalized that his daughter was last checked on (b)(6) 2019 and stated that there were still corneal erosions near the center of cornea of both eyes.However, no mention on the percentage of the epithelial loss/erosion in the corneal surface, possibly still 10% of total surface.Received additional information on (b)(6) 2019 stating the medical treatment by the eye care professional (ecp) as follows, trehalose (3%) and hyaluronic acid (0.15%) eye drops, to be given two to three times a day for ten days.The consumer was instructed to resume wearing contact lenses in ten days (new contact lenses without hydraglyde).Lastly, the consumer was instructed to come back for follow up one to three months for co and fao.Received additional information on (b)(6) 2019, the consumer¿s father reported that the consumer does not have any more pain.The consumer¿s visual acuity has been restored and now sees and feels completely normal.The consumer¿s father added that the consumer¿s right eye which has been more affected during the incident has now +0.5 refractive power compared to -0.5 before the incident.Additional information has been requested but not yet received.

Manufacturer Narrative

The complaint product was returned for evaluation and was found to meet manufacturing specifications.A retention sample was chemistry tested.The results were within specifications.A comprehensive review was performed including review of the mbrs, complaint history, sanitization records, bioburden records, incoming component inspection results, in process and finished product testing results, formulation stability data, and environmental/utility sample results.The review shows that the manufacturing processes were in a state of control.Based on acceptable mbr review, complaint history, sanitization records, bioburden records, incoming component inspection results, in process and finished product testing results, formulation stability data, and environmental/utility sample results, this lot continues to be acceptable.Root cause could not be determined.The manufacturer internal reference number is: (b)(4).

Event Description

As initially reported by a consumer¿s father thru email on 09jan2019, the consumer was diagnosed with acute painful bilateral corneal erosions, abrasions and conjunctival erythema dated (b)(6) 2019 with medical reports attached.This was believed to be the result of the consumer cleaning her biofinity coopervision contacts with novartis/alcon¿s aosept plus with hydraglyde.The appellant reported that the consumer had experienced severe impaired vision on both eyes and could see ¿rainbow/halos¿ around light sources, also she complained of swollen, red eyes with acute pain which she described as stinging and burning with severe discomfort and sensitivity to light.On the report, the consumer had been using peroxide-based solution for a couple of years and said to adhere to the safety precaution of the product used and she just had recently switched to aosept plus with hydraglyde.She also added, that the consumer also uses the product for soaking contact lenses to be neutralized for eight hours without any issue and just before the incident the consumer had kept her lenses in a container with neutralizer for one week before using the contact lenses.She initially just experienced haziness in vision in the afternoon and excessive tearing during the night.However, at around 3:00 in the morning the consumer woke up to swollen, red eyes with excruciating pain and impaired visual acuity opting them to rush the client to the emergency department.Received additional information on 10jan2019 stating the medications used by the consumer: sodium hyaluronate and xanthan gum eye gel, trehalose (3%) and hyaluronic acid (0.15%) eye drops and dexpanthenol eye gel with unknown duration and frequency.Received additional information on 14jan2019 stating the consumer¿s eye status is getting much better.No more discomfort, no burning and stinging sensations reported, and no more excessive tearing.Also, the consumer¿s father verbalized that his daughter was last checked on 10jan2019 and stated that there were still corneal erosions near the center of cornea of both eyes.However, no mention on the percentage of the epithelial loss/erosion in the corneal surface, possibly still 10% of total surface.Received additional information on 16jan2019 stating the medical treatment by the eye care professional (ecp) as follows, trehalose (3%) and hyaluronic acid (0.15%) eye drops, to be given two to three times a day for ten days.The consumer was instructed to resume wearing contact lenses in ten days (new contact lenses without hydraglyde).Lastly, the consumer was instructed to come back for follow up one to three months for co and fao.Received additional information on 16jan2019, the consumer¿s father reported that the consumer does not have any more pain.The consumer¿s visual acuity has been restored and now sees and feels completely normal.The consumer¿s father added that the consumer¿s right eye which has been more affected during the incident has now +0.5 refractive power compared to -0.5 before the incident.Additional information has been requested but not yet received.

• Brand Name: AOSEPT PLUS/CLEAR CARE PLUS WITH HYDRAGLYDE CLEANING AND DISINFECTING SOLUTION
• Type of Device: ACCESSORIES, SOFT LENS PRODUCTS
• Manufacturer (Section D): ALCON RESEARCH, LLC; 6201 south freeway; fort worth TX 76134
• MDR Report Key: 8291625
• MDR Text Key: 134566346
• Report Number: 1610287-2019-00003
• Device Sequence Number: 1
• Product Code: LPN
• Combination Product (y/n): N
• PMA/PMN Number: K142284
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other
• Type of Report: Initial,Followup
• Report Date: 04/26/2019

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 Expiration Date: 11/30/2019
• Device Catalogue Number: 0003630004
• Device Lot Number: 290857F
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/25/2019
• Initial Date Manufacturer Received: 01/09/2019
• Initial Date FDA Received: 01/31/2019
• Supplement Dates Manufacturer Received: 04/09/2019
• Supplement Dates FDA Received: 04/26/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 30 YR