FDA.reportPublic FDA data

MAUDE MDR 9842456

MDR report key
9842456
Report number
2028159-2020-00242
Event key
0
Event type
3
Date of event
2020-02-19
Date received
2020-03-17
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
1
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
MR. JONATHAN SCHLECH
Address
6201 SOUTH FREEWAY MAIL STOP AB2-6 FORT WORTH TX 76134 US
Phone
817-817-8175
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1LENSX LASER SYSTEMOPHTHALMIC FEMTOSECOND LASERALCON LENSX, INC.OOE5508065998162ASKUR N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12020-03-1701. R

Event Narratives#

N

Patient 1

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).

D

Patient 1

A CUSTOMER REPORTED A PATIENT WITH INFLAMMATION AND MILD HAZE IN BOTH EYES POST LASER TREATMENT. THE TOPICAL STEROID DOSAGE WAS INCREASED. ADDITIONAL INFORMATION RECEIVED STATES THE PATIENT DEVELOPED CTK (CENTRAL TOXIC KERATOPATHY). THERE ARE TWO RELATED REPORTS FOR THIS PATIENT. THIS REPORT ADDRESSES THE PATIENT'S RIGHT EYE, AND ANOTHER MANUFACTURER REPORT WILL BE FILED FOR THE FELLOW EYE.