TECNIS 1 MULTIFOCAL ZLB00 ZLB00I0240

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-03-23 for TECNIS 1 MULTIFOCAL ZLB00 ZLB00I0240 manufactured by Johnson & Johnson Surgical Vision, Inc..

Event Text Entries

[188489631] 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.
Patient Sequence No: 1, Text Type: N, H10


[188489632] It was reported that during implantation of an intraocular lens (model zlb00 24. 0 diopter) in patient? S left eye (os), 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. 5, visual acuity post-operative: 0. 8. The patient had bilateral lenses implanted. This report will capture the lens implanted in the patient's left eye (os). A separate report will be filed for the right eye (od).
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number9614546-2020-00136
MDR Report Key9864290
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2020-03-23
Date of Report2020-03-22
Date of Event2020-02-06
Report Date2005-01-01
Date Reported to FDA2005-01-01
Date Reported to Mfgr2005-01-10
Date Mfgr Received2020-02-24
Date Added to Maude2020-03-23
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 StreetVAN SWIETENLAAN 5
Manufacturer CityGRONINGEN 9728NX
Manufacturer CountryNL
Manufacturer Postal Code9728 NX
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Sequence Number: 1

Brand NameTECNIS 1 MULTIFOCAL
Generic NameMULTIFOCAL IOLS
Product CodeMFK
Date Received2020-03-23
Returned To Mfg2020-03-12
Model NumberZLB00
Catalog NumberZLB00I0240
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 Received2020-03-23
Device Sequence No101
Device Event Key0


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2020-03-23

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