FDA.reportPublic FDA data

MAUDE MDR 9848913

MDR report key
9848913
Report number
3006695864-2020-00188
Event key
0
Event type
3
Date of event
2020-02-21
Date received
2020-03-18
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
SOMYATA NAGPAL
Address
1700 EAST ST. ANDREW PLACE SANTA ANA CA 92705 US
Phone
714-714-7142
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1IFSFEMTOSECOND LASERJOHNSON & JOHNSON SURGICAL VISION, INC.HNOJ20007DJ20007D Y
101---

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12020-03-1801. R

Event Narratives#

N

Patient 1

A REVIEW OF RECORDS RELATED TO THE DEVICE INCLUDING LABELING, COMPLAINT TRENDING, AND RISK DOCUMENTATION WILL BE PERFORMED. UPON COMPLETION OF THIS REVIEW, IF THERE IS ANY FURTHER RELEVANT INFORMATION OBTAINED, A SUPPLEMENTAL MEDWATCH WILL BE FILED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC HAS BEEN SUBMITTED.

D

Patient 1

IT WAS REPORTED THAT A LASER VISION CORRECTION PATIENT HAD SURGERY ON (B)(6) 2020 AND PRESENTED ON (B)(6) 2020 WITH FIBER UNDER FLAP EMERGING AT NASAL FLAP EDGE IN RIGHT EYE. IT WAS STATED THAT THE PATIENT HAD NO LOSS OF BEST CORRECTED VISUAL ACUITY (BCVA). THE PATIENT COMPLAINED OF DRY EYE AND FOREIGN BODY SENSATION IN RIGHT EYE. PATIENT REPORTED SYMPTOMS ARE NOT INTERFERING WITH DAILY ACTIVITIES AND FIBER WAS REMOVED WITH FORCEPS. BCVA FROM (B)(6) 2020: RIGHT EYE PRE-OP 20/20 -.25 X -.75 X 85, LEFT EYE PRE-OP 20/20 -.50 X -.50 X 85. THIS REPORT IS FOR THE INTRALASE LASER. A SEPARATE REPORT IS BEING SUBMITTED FOR THE VISX.