FDA.reportPublic FDA data

MAUDE MDR 9908582

MDR report key
9908582
Report number
2648035-2020-00304
Event key
0
Event type
3
Date of event
2020-02-18
Date received
2020-03-31
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-PIECEMONOFOCAL IOLSJOHNSON & JOHNSON SURGICAL VISION, INC.HQLZCB00ZCB0000305 R
101---

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12020-03-3101. R

Event Narratives#

N

Patient 1

(B)(4). IF IMPLANTED, IF EXPLANTED, GIVE DATE: NOT APPLICABLE AS LENS WAS REMOVED/REPLACED WITHIN THE SAME SURGERY. DEVICE EVALUATION: THE ORIGINAL FOLDING CARTON AND DIRECTIONS FOR USE WERE RECEIVED. VISUAL INSPECTION UNDER MAGNIFICATION REVEALED VISCOELASTIC RESIDUE ON THE OPTIC BODY AND HAPTICS. THE LENS WAS RECEIVED CUT IN HALF, WHICH IS CONSISTENT WITH A LENS THAT WAS HANDLED DURING EXPLANT. BASED ON THE RETURN CONDITION OF THE LENS NO PRODUCT EVALUATION COULD BE PERFORMED. THE COMPLAINT ISSUE COULD NOT BE CONFIRMED, AND NO PRODUCT DEFICIENCY WAS IDENTIFIED. MANUFACTURING RECORD REVIEW: THE MANUFACTURING RECORDS FOR THE PRODUCT WERE REVIEWED. THE PRODUCT WAS MANUFACTURED AND RELEASED ACCORDING TO SPECIFICATIONS. THE COMPLAINT SEARCH FOUND 1 REPORT BUT IT'S NOT RELATED TO THE REPORTED EVENT. CONCLUSION: AS A RESULT OF THE INVESTIGATION THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY AND THE REPORTED ISSUE COULD NOT BE VERIFIED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

D

Patient 1

IT WAS REPORTED THAT A ZCB00 IOL 30.5 DIOPTER WAS INSERTED INTO THE PATIENT?S OPERATIVE EYE. AFTER INSERTION THE DOCTOR NOTICED A TEAR IN THE LENS. THE IOL WAS REMOVED AND REPLACED DURING THE SAME PROCEDURE WITH THE SAME MODEL. THE INCISION WAS ENLARGED. NO FURTHER INFORMATION WAS PROVIDED.