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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CIBA VISION GMBH PRECISION1 FOR ASTIGMATISM; LENSES, SOFT CONTACT, DAILY WEAR
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CIBA VISION GMBH PRECISION1 FOR ASTIGMATISM; LENSES, SOFT CONTACT, DAILY WEAR Back to Search Results
Model Number 0000000000
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Corneal Ulcer (1796)
Event Date 02/28/2021
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
¿initial report received by the sale rep on behalf of the ecp via email.It was reported that on an unspecified date the patient who was on trial precision 1 for astigmatism vs.Oasys 1 day for astigmatism experienced an ulcer.Symptoms resolution is unknown.Additional information has been requested but not yet available.
 
Manufacturer Narrative
B.5.:  additional information received; based upon the review of the facts available at this time, this complaint is no longer considered serious or reportable.The manufacturer internal reference number is: (b)(4).
 
Event Description
¿initial report received by the sale rep on behalf of the ecp via email.It was reported that on an unspecified date the patient who was on trial precision 1 for astigmatism vs.Oasys 1 day for astigmatism experienced an ulcer.Symptoms resolution is unknown.Additional information has been received on (b)(6) 2021 states that consumer was diagnosed with corneal ulcer in left eye located in the peripheral nasal region with diagnosis code h16.042.Consumer also experienced pain.No anterior chamber reaction or infiltrates were noted.No corneal staining was diagnosed.Symptoms are resolved after taking prescription drops.
 
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Brand Name
PRECISION1 FOR ASTIGMATISM
Type of Device
LENSES, SOFT CONTACT, DAILY WEAR
Manufacturer (Section D)
CIBA VISION GMBH
postfach, industriering 1
grosswallstadt D-638 68
GM  D-63868
MDR Report Key11567709
MDR Text Key242210016
Report Number9610813-2021-00006
Device Sequence Number1
Product Code LPL
Combination Product (y/n)N
PMA/PMN Number
K182902
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Type of Report Initial,Followup
Report Date 04/06/2021
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 Model Number0000000000
Device Catalogue Number0000000000
Device Lot NumberASKU
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 03/10/2021
Initial Date FDA Received03/25/2021
Supplement Dates Manufacturer Received03/26/2021
Supplement Dates FDA Received04/06/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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