FDA.reportPublic FDA data

MAUDE MDR 9795570

MDR report key
9795570
Report number
2020664-2020-00018
Event key
0
Event type
3
Date received
2020-03-05
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
0
Initial report to FDA
0
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
1TECNIS SYMFONYMULTIFOCAL IOLSJOHNSON & JOHNSON SURGICAL VISION, INC.POEZXR00ZXR00U0190 N
101---

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12020-03-0501. R

Event Narratives#

N

Patient 1

(B)(4). ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

N

Patient 1

DATE OF EVENT: UNKNOWN, INFORMATION NOT PROVIDED. IF EXPLANTED, GIVE DATE: NOT APPLICABLE, LENS HAS NOT BEEN EXPLANTED. THE INTRAOCULAR LENS (IOL) IS NOT RETURNING FOR EVALUATION AS IT REMAINS IMPLANTED; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE CANNOT BE COMPLETED. A REVIEW OF THE DEVICE HISTORY RECORD, LABELING, COMPLAINT TRENDING, AND RISK DOCUMENTATION FOR THIS DEVICE WILL BE PERFORMED. UPON COMPLETION OF THE REVIEW, IF THERE IS ANY FURTHER RELEVANT INFORMATION A SUPPLEMENTAL MEDWATCH WILL BE FILED. NOTE: THE DEVICE WAS MANUFACTURED AT THE KULIM SITE WHICH HAS BEEN CLOSED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

D

Patient 1

IT WAS REPORTED THAT A PATIENT HAS BILATERAL ZXR00 INTRAOCULAR LENSES (IOL) IMPLANTED. HOWEVER, THE PATIENT IS EXPERIENCING CIRCLES AND GLARE IN THE FORM OF A HUGE STARBURST AT NIGHT, WHICH HAS LIMITED THE PATIENT FROM DRIVING AT NIGHTTIME. THE SYMPTOMS ARE ALMOST IDENTICAL IN EACH EYE. BOTH LENSES ARE STILL IMPLANTED. PATIENT HAS SEEN HIS EYE DOCTOR MULTIPLE TIMES AND WAS USING EYE DROPS. PER THE PATIENT, NOTHING HAS WORKED TO BETTER HIS NIGHT VISION. PATIENT STATES DAY VISION IS PERFECT BUT IS CONSIDERING A SECOND OPINION TO ADDRESS NIGHT VISION. NO FURTHER INFORMATION WAS PROVIDED. THIS REPORT CAPTURES THE EVENT FOR THE LEFT EYE. A SEPARATE REPORT IS BEING SUBMITTED FOR THE RIGHT EYE.