TECNIS 1-PIECE ZCB00 ZCB0000305

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2020-03-31 for TECNIS 1-PIECE ZCB00 ZCB0000305 manufactured by Johnson & Johnson Surgical Vision, Inc..

Event Text Entries

[187706159] (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.
Patient Sequence No: 1, Text Type: N, H10


[187706160] 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.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2648035-2020-00304
MDR Report Key9908582
Report SourceHEALTH PROFESSIONAL,USER FACI
Date Received2020-03-31
Date of Report2020-03-31
Date of Event2020-02-18
Report Date2005-01-01
Date Reported to FDA2005-01-01
Date Reported to Mfgr2005-01-10
Date Mfgr Received2020-03-04
Date Added to Maude2020-03-31
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactSOMYATA NAGPAL
Manufacturer Street1700 EAST ST. ANDREW PLACE
Manufacturer CitySANTA ANA CA 92705
Manufacturer CountryUS
Manufacturer Postal92705
Manufacturer Phone7142478200
Manufacturer G1JOHNSON & JOHNSON SURGICAL VISION, INC.
Manufacturer StreetROAD 402 NORTH, KM 4.2 ANASCO INDUSTRIAL PARK
Manufacturer CityANASCO PR 00610
Manufacturer CountryUS
Manufacturer Postal Code00610
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Sequence Number: 1

Brand NameTECNIS 1-PIECE
Generic NameMONOFOCAL IOLS
Product CodeHQL
Date Received2020-03-31
Returned To Mfg2020-03-25
Model NumberZCB00
Catalog NumberZCB0000305
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device Sequence No1
Device Event Key0
ManufacturerJOHNSON & JOHNSON SURGICAL VISION, INC.
Manufacturer Address1700 E ST ANDREW PLACE SANTA ANA CA 92705 US 92705

Device Sequence Number: 101

Product Code---
Date Received2020-03-31
Device Sequence No101
Device Event Key0


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2020-03-31

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