FDA.reportPublic FDA data

MAUDE MDR 9827553

MDR report key
9827553
Report number
9614546-2020-00121
Event key
0
Event type
3
Date received
2020-03-12
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 SYMFONYMULTIFOCAL IOLSJOHNSON & JOHNSON SURGICAL VISION, INC.POEZXR00ZXR00U0185 R
101---

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12020-03-1201. R

Event Narratives#

N

Patient 1

ADDITIONAL INFORMATION: DATE OF EVENT: UNKNOWN AS INFORMATION WAS NOT PROVIDED. THE BEST ESTIMATE DATE IS BETWEEN (B)(6) 2018 AND (B)(6) 2019. (B)(4). DEVICE EVALUATION: THE LENS WAS RECEIVED STUCK TO FOAM IN A SMALL BOX, AND A COMPLETED COMPLAINT PRODUCT SHIPPING GUIDE WAS ALSO RECEIVED. VISUAL INSPECTION UNDER MAGNIFICATION REVEALED THAT THE LENS WAS RECEIVED ALMOST CUT IN HALF (BUT NOT SEPARATED), WHICH IS CONSISTENT WITH A LENS THAT WAS HANDLED DURING EXPLANT. ADDITIONALLY, VISCOELASTIC RESIDUE WAS OBSERVED ON THE OPTIC BODY AND HAPTICS. PARTICLES WERE OBSERVED ON THE LENS, WHICH CAN BE ATTRIBUTED TO RECEIVING THE LENS STUCK TO FOAM. BASED ON THE CONDITION OF THE RETURN LENS NO FURTHER PRODUCT EVALUATION COULD BE PERFORMED. NO COMPLAINT ISSUE COULD NOT BE CONFIRMED, AND NO PRODUCT DEFICIENCY WAS IDENTIFIED. MANUFACTURING RECORDS REVIEW: THE MANUFACTURING RECORDS FOR THE PRODUCT WERE REVIEWED, THE PRODUCT WAS MANUFACTURED AND RELEASED ACCORDING TO SPECIFICATION. HISTORICAL DATA ANALYSIS: A SEARCH REVEALED THAT NO OTHER COMPLAINTS FOR THIS PRODUCTION ORDER NUMBER HAVE BEEN RECEIVED. CONCLUSION: AS A RESULT, OF THE INVESTIGATION THERE IS NO INDICATION OF A PRODUCT MALFUNCTION OR PRODUCT QUALITY DEFICIENCY. THE REPORTED ISSUE WAS NOT VERIFIED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

D

Patient 1

IT WAS REPORTED ZXR00 18.5 INTRAOCULAR LENSES (IOL) WAS IMPLANTED IN THE PATIENT?S LEFT EYE ON (B)(6) 2018 AND REPORTED COMPLAINTS OF GLARE. THROUGH FOLLOW UP, ADDITIONAL INFORMATION WAS RECEIVED STATING ZXR00 18.5 DIOPTER LENS WAS EXPLANTED (B)(6) 2019 DUE TO ADDITIONAL COMPLAINTS OF HYPEROPIC ASTIGMATIC OUTCOME, POSITIVE DYSPHOTOPSIA, VERY POOR NIGHT VISION DUE TO GLARE - UNABLE TO DRIVE AT NIGHT, AND REPLACED WITH A NON-JOHNSON & JOHNSON SURGICAL VISION LENS. THERE WAS NO INCISION ENLARGEMENT AND NO PATIENT INJURY. VITRECTOMY (PARS PLANA VITRECTOMY - PPV) AND LIMBAL RELAXING INCISION(S) (LRI) WERE PERFORMED. PATIENT OUTCOME REPORTED AS: PATIENT HAPPY AND FEELS THAT SYMPTOMS HAVE RESOLVED. NO ADDITIONAL INFORMATION WAS PROVIDED TO JOHNSON & JOHNSON SURGICAL VISION.