FDA.reportPublic FDA data

MAUDE MDR 9905400

MDR report key
9905400
Report number
2028159-2020-00302
Event key
0
Event type
3
Date received
2020-03-31
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 RESEARCH, LLC - IRVINE TECHNOLOGY CENTEROOE5508065998162ASKUR N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12020-03-3101. O

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 DOCTOR REPORTED HE THINKS THE LASER COULD HAVE CAUSED A CUT IN THE POSTERIOR CAPSULAR BAG DURING FRAGMENTATION OF THE NUCLEUS OF THE LENS. THE DOCTOR IS VERY EXPERIENCED AND HAS BEEN WORKING WITH THIS LASER FOR MANY YEARS AND THIS IS THE FIRST TIME THIS HAS OCCURRED. THE SURGERY WAS COMPLETED. THE INTRAOCULAR LENS WAS IMPLANTED IN TO THE FURROW AND NOT THE CAPSULAR BAG.