FDA.reportPublic FDA data

MAUDE MDR 9901763

MDR report key
9901763
Report number
2648035-2020-00300
Event key
0
Event type
3
Date received
2020-03-30
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
1UNKNOWNMONOFOCAL IOLSJOHNSON & JOHNSON SURGICAL VISION, INC.HQLUNKNOWNUNKNOWN N
101---

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12020-03-300

Event Narratives#

N

Patient 1

AGE/DATE OF BIRTH: UNKNOWN/NOT PROVIDED. SEX/GENDER: UNKNOWN/NOT PROVIDED. DATE OF EVENT: UNKNOWN, NOT PROVIDED. BRAND NAME: UNKNOWN AS PRODUCT SERIAL NUMBER WAS NOT PROVIDED. MODEL NUMBER: UNKNOWN AS PRODUCT SERIAL NUMBER WAS NOT PROVIDED. CATALOG NUMBER: UNKNOWN AS PRODUCT SERIAL NUMBER WAS NOT PROVIDED. EXPIRATION DATE: UNKNOWN AS PRODUCT SERIAL NUMBER WAS NOT PROVIDED. SERIAL NUMBER: UNKNOWN AS THE INFORMATION WAS NOT PROVIDED. UDI NUMBER: UDI # IS UNKNOWN AS PRODUCT SERIAL NUMBER WAS NOT PROVIDED. IF IMPLANTED; GIVE DATE: UNKNOWN/ NOT PROVIDED. IF EXPLANTED; GIVE DATE: NOT APPLICABLE AS THE IOL REMAINS IMPLANTED IN THE PATIENT'S EYE. (B)(6). PMA/510(K) NUMBER: UNKNOWN AS IOL PRODUCT SERIAL NUMBER INFORMATION WAS NOT PROVIDED. THE PRODUCT SERIAL NUMBER FOR THIS DEVICE IS NOT AVAILABLE AND THE LENS ALSO REMAINS IMPLANTED; THEREFORE, NO FURTHER INVESTIGATION CAN BE PERFORMED. IF THERE IS ANY FURTHER RELEVANT INFORMATION RECEIVED, A SUPPLEMENTAL MEDWATCH REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN AS PRODUCT SERIAL NUMBER WAS NOT PROVIDED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON AND JOHNSON SURGICAL VISION HAS BEEN SUBMITTED.

D

Patient 1

IT WAS REPORTED THAT A FIBER/MATTER WAS DISCOVERED INSIDE THE EYE, ON THE LENS IN FOUR (4) OCCASIONS. THE FIBER WAS REMOVED AND IT WAS DESCRIBED BY THE DOCTOR AS BEING SIMILAR TO SILICONE OR PLASTIC LOOKING, SOFT AND STICKY. IT WAS INDICATED THAT THE LENS REMAINS IMPLANTED AND THERE IS NO PLAN FOR AN EXPLANT PROCEDURE. THERE WERE NO SURGICAL INTERVENTION SUCH AS VITRECTOMY, INCISION ENLARGEMENT, OR SUTURES REQUIRED. IT WAS INDICATED THAT NO SAMPLES WERE KEPT IN THESE CASES. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS REPORT IS THREE (3) OUT OF FOUR. SEPARATE REPORTS ARE BEING SUBMITTED FOR THE OTHER THREE EVENTS.