MAUDE Adverse Event Report: ALCON RESEARCH, LLC CLEAR CARE; ACCESSORIES, SOFT LENS PRODUCTS

Lot Number ASKU

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

Patient Problems Corneal Ulcer (1796); Erythema (1840); Inflammation (1932); Keratitis (1944)

Event Type  Injury  

Manufacturer Narrative

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 health professional via literature on (b)(6) 2020, it was reported that out of 76 patients 58 patients have experienced corneal inflammatory events (cie) which includes contact lens peripheral ulcer (clpu) and infiltrative keratitis (contact lens acute red eye, contact lens associated infiltrative keratitis, asymptomatic infiltrates, asymptomatic infiltrative keratitis, or scattered infiltrates).Mixed, conditions where two of the three listed above were present simultaneously.The outcome of the events were not reported.

Manufacturer Narrative

H.3., h.6.: no sample or lot code was returned; therefore, lot specific evaluation cannot be completed, at this time.All lens care products undergo microbial and chemistry in process and finished product testing.All compounding and filling mbrs are subjected to 2 independent reviews.In addition, prior to product release, the following are reviewed: all chemistry and microbial finished product results, environmental, utility records, sanitization records.All product are compounded in the fwn facility using a stationary stainless steel mix tank.The sterilization of the product is achieved by in-line filtration using sterilizing membrane filters.Filling is performed in a grade a area (class 100).As part of the mbr review, all filter integrity tests are confirmed to be acceptable.Filling areas are routinely monitored for environmental (temperature, humidity, air pressure, viable and non viable particulates).The primary components (bottles and closures) are produced under controlled conditions and are double bagged and placed into shippers from the supplier.The shippers and the components inside are sterilized prior to being sent to the company.The incoming components are evaluated to ensure that all key attribute, dimensional, and sterilization requirements are met prior to disposition.The product literature provided on the inside of the product carton states under warning: the following problems may occur with contact lens wear: eyes sting, burn or itch (irritation), comfort is less than when lens was first placed on the eye, feeling of something in the eye (foreign body, scratched area), excessive watering (tearing) of the eye, unusual eye secretions, redness of the eye, reduced sharpness of vision (poor visual acuity), blurred vision, rainbows or halos around objects, sensitivity to light (photophobia), or dry eyes.Also, the literature lists under precautions: ¿ always wash and dry your hands before handling your lenses.¿ never use this for heat disinfection.¿ never reuse this solution.¿ keep bottle tightly closed when not in use.¿ store at room temperature.(15°c to 30°c / 59°f to 86°f) ¿ use before the expiration date marked on the container.¿ once bottle is open, discard any remaining solution after 3 months.Root cause of the complaint condition could not be determined; the lot code and sample were not provided.Potential root causes that could be associated with the complaint conditions include: ¿ solution quality issue ¿ unlikely, as chemistry and microbiology data is reviewed and verified to meet regulatory requirements prior to release.¿ consumer mishandling - no conclusion can be made regarding the contribution of consumer mishandling as this factor is outside the control of the manufacturing facility.¿ event related to consumer physiology ¿ no conclusion can be made regarding the contribution of unique consumer physiology as this factor is outside the control of the manufacturing facility.¿ event unrelated to product use - no conclusion can be made regarding this root cause based on information available.Customer product use and storage practice could not be confirmed.No further action is warranted at this time.Lot specific evaluation is not possible without a lot code.The manufacturer internal reference number is: (b)(4).

Manufacturer Narrative

H.3., h.6.: the lot number was not provided and the complaint sample was not made available for evaluation.Prior to product release, all chemistry and microbial finished product results, environmental, utility records and sanitization records were reviewed.The manufacturing review did not indicate that this complaint was due to the manufacturing process.No complaint was identified.The root cause could not be determined.The manufacturer internal reference number is: (b)(4).

Manufacturer Narrative

Correction in a.1, b.5, b.6, h.6, h.8: supplemental medical device report is being filed to correct the safety narrative, device usage.Incorrect device usage from asku is being changed to initial use and safety narrative updated as per article.The manufacturer internal reference number is: (b)(4).

Event Description

As reported the prospective study of contact lens daily wearer and extended wearer was performed, in which out of 76 patients 58 patients have experienced corneal inflammatory events (cie) which includes contact lens peripheral ulcer (clpu), infiltrative keratitis (contact lens acute red eye, contact lens associated infiltrative keratitis, asymptomatic infiltrates, asymptomatic infiltrative keratitis, or scattered infiltrates) and phlyctenular-like condition defined as limbal edema with adjacent, but localized, corneal edema and infiltrates.Mixed, conditions where two of the three listed above were present simultaneously.The treatment medication included steroid and antibiotic combination, followed by antibiotic only or steroid only.The outcome of the events were not reported.No further information is available.

• Brand Name: CLEAR CARE
• Type of Device: ACCESSORIES, SOFT LENS PRODUCTS
• Manufacturer (Section D): ALCON RESEARCH, LLC; 6201 south freeway; fort worth TX 76134
• Manufacturer (Section G): ALCON RESEARCH, LLC; 6201 south freeway; fort worth TX 76134
• Manufacturer Contact: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8007579780
• MDR Report Key: 9843480
• MDR Text Key: 184461767
• Report Number: 1610287-2020-00012
• Device Sequence Number: 1
• Product Code: LPN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K031521
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 03/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/17/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/02/2022
• 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: Initial
• Removal/Correction Number: CORRECTION
• Patient Sequence Number: 1
• Patient Outcome(s): Other