FDA.reportPublic FDA data

MAUDE MDR 9815710

MDR report key
9815710
Report number
9614546-2020-00115
Event key
0
Event type
3
Date received
2020-03-11
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 SYMFONY TORICMULTIFOCAL IOLSJOHNSON & JOHNSON SURGICAL VISION, INC.POEZXT150ZXT150U165 R
101---

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12020-03-1101. R

Event Narratives#

N

Patient 1

DATE OF EVENT: NOT PROVIDED, BEST ESTIMATE DATE IS BETWEEN (B)(6) 2019 - (B)(6) 2020. (B)(4). DEVICE EVALUATION: THE LENS WAS RECEIVED IN A SPECIMEN CUP SUBMERGED IN AN UNKNOWN LIQUID. VISUAL INSPECTION WITH THE UNAIDED EYE REVEALED THAT THE LENS WAS RECEIVED CUT AT THE BASE OF ONE HAPTIC (NO HAPTIC RECEIVED), WHICH IS CONSISTENT WITH A LENS THAT WAS HANDLED DURING EXPLANT. ADDITIONALLY, A SECOND HAPTIC WAS OBSERVED TO BE DETACHED (NO HAPTIC RECEIVED). NO COSMETIC DEFECTS WERE OBSERVED ON THE OPTIC BODY. BASED ON THE CONDITION OF THE RETURN LENS, NO FURTHER PRODUCT EVALUATION COULD BE PERFORMED (VISUAL INSPECTION OF HAPTICS). THE 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. A SEARCH REVEALED THAT NO OTHER COMPLAINTS HAVE BEEN RECEIVED FOR THIS PRODUCTION ORDER. 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 A SYMFONY INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM PATIENT'S RIGHT EYE DUE TO THE PATIENT EXPERIENCING HALO AND GLARE. THE REPLACEMENT LENS IS A THREE PIECE NON-JOHNSON & JOHNSON IOL. THE PATIENT IS REPORTED TO BE DOING WELL POST-EXCHANGE. NO FURTHER INFORMATION PROVIDED.