FDA.reportPublic FDA data

MAUDE MDR 9864306

MDR report key
9864306
Report number
9614546-2020-00137
Event key
0
Event type
3
Date of event
2020-02-07
Date received
2020-03-23
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
1TECNIS 1 MULTIFOCALMULTIFOCAL IOLSJOHNSON & JOHNSON SURGICAL VISION, INC.MFKZKB00ZKB00I0240 R
101---

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12020-03-2301. R

Event Narratives#

N

Patient 1

INITIAL REPORTER PHONE: (B)(6). (B)(4). DEVICE EVALUATION: THE RETURNED SAMPLE WAS EVALUATED. VISUAL INSPECTION WITH THE UNAIDED EYE REVEALED VISCOELASTIC RESIDUE ON THE OPTIC BODY AND HAPTICS, AND THAT THE LENS WAS RECEIVED CUT IN HALF, WHICH IS CONSISTENT WITH A LENS THAT WAS HANDLED DURING EXPLANT. DIMENSIONAL INSPECTION WAS PERFORMED ON BOTH HAPTIC WIDTHS AND THICKNESS, AND THE MEASUREMENTS WERE WITHIN SPECIFICATIONS. BASED ON THE RETURN CONDITION OF THE LENS NO FURTHER PRODUCT EVALUATION (FURTHER VISUAL INSPECTION AND ADDITIONAL DIMENSIONAL INSPECTION) COULD BE PERFORMED. THE COMPLAINT ISSUE COULD NOT BE CONFIRMED, AND NO PRODUCT DEFICIENCY WAS IDENTIFIED. MANUFACTURING RECORD REVIEW: THE MANUFACTURING PROCESS RECORD WAS EVALUATED AND NO DEVIATION WAS FOUND DURING PROCESS RELATED TO THE COMPLAINT ISSUE REPORTED. THE PRODUCT WAS MANUFACTURED AND RELEASED ACCORDING TO SPECIFICATIONS. A SEARCH REVEALED THAT NO OTHER COMPLAINTS HAVE BEEN RECEIVED FOR THIS PRODUCTION ORDER NUMBER. CONCLUSION: AS A RESULT OF THE INVESTIGATION THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

D

Patient 1

IT WAS REPORTED THAT DURING IMPLANTATION OF AN INTRAOCULAR LENS (MODEL ZKB00 24.0 DIOPTER) IN PATIENT?S RIGHT EYE (OD) THERE WAS A STUCK CARTRIDGE ISSUE. THEY MANAGED TO FINISH UP THE SURGERY, BUT SOME MARKS ON OPTIC ZONE WERE NOTED WHEN EXAMINED AFTER THE OPERATION. THE PATIENT COMPLAINED ABOUT DISCOMFORT OF VISION DUE TO BLUR SPOT. REPORTEDLY THE LENS WAS EXPLANTED IN A SECONDARY SURGICAL PROCEDURE. LENS FROM ANOTHER MANUFACTURER WAS USED AS REPLACEMENT FOR THE PATIENT. NO FURTHER INFORMATION PROVIDED. VISUAL ACUITY PRE-OPERATIVE: 0.6, VISUAL ACUITY POST-OPERATIVE: 0.9. THE PATIENT HAD BILATERAL LENSES IMPLANTED. THIS REPORT WILL CAPTURE THE LENS IMPLANTED IN THE PATIENT'S RIGHT EYE (OD). A SEPARATE REPORT WILL BE FILED FOR THE LEFT EYE (OS).