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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ALCON RESEARCH, LLC OPTI-FREE PUREMOIST MULTI-PURPOSE DISINFECTING SOLUTION; ACCESSORIES, SOFT LENS PRODUCTS

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ALCON RESEARCH, LLC OPTI-FREE PUREMOIST MULTI-PURPOSE DISINFECTING SOLUTION; ACCESSORIES, SOFT LENS PRODUCTS Back to Search Results
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
H.3., h.6.: 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 55 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.: chemistry and micro data must meet regulatory requirements prior to each batch.A sample or lot code would be required for further investigation.As insufficient information was provided for investigation, a conclusive root cause cannot be determined for the corneal ulcer infectious, corneal infiltrate, corneal edema, and miscellaneous event - ocular complaint conditions.Consumer mishandling, consumer physiology, and unrelated events could not be eliminated as potential root causes.Potential root causes of corneal ulcer infectious, corneal infiltrate, corneal edema, and miscellaneous event - ocular complaint condition include: ¿ solution quality issue ¿ unlikely, as chemistry and microbiology results must meet regulatory requirements prior to release of a lot.¿ 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.A sample or lot code would be required for review of the analytical testing results and complaint history associated with the reported lot.Insufficient information provided to determine a conclusive root cause for the corneal ulcer infectious, corneal infiltrate, corneal edema, and miscellaneous event - ocular complaint conditions.The manufacturer internal reference number is: (b)(4).
 
Manufacturer Narrative
Correction in d.1, d.3, and corrected information in g.9.The initial mdr and first follow-up report were incorrectly under mfr report# 1610287-2020-00013.This report references the correct mfr report # 1610287-2022-00010.All future reports associated with this product event will be submitted under report # 1610287-2022-00010.The manufacturer internal reference number is: (b)(4).
 
Manufacturer Narrative
H3, h6: 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).
 
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Brand Name
OPTI-FREE PUREMOIST MULTI-PURPOSE DISINFECTING SOLUTION
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 Key9843477
MDR Text Key183920035
Report Number1610287-2020-00013
Device Sequence Number1
Product Code LPN
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K102860
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Literature
Reporter Occupation Other Health Care Professional
Remedial Action Other
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
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Lot NumberASKU
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 02/19/2020
Initial Date FDA Received03/17/2020
Supplement Dates Manufacturer Received04/21/2020
01/26/2022
03/04/2022
Supplement Dates FDA Received04/22/2020
02/12/2022
03/24/2022
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 NumberCORRECTION
Patient Sequence Number1
Patient Outcome(s) Other;
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