TECNIS 1 MULTIFOCAL ZLB00 ZLB00U0200

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2020-03-16 for TECNIS 1 MULTIFOCAL ZLB00 ZLB00U0200 manufactured by Johnson & Johnson Surgical Vision, Inc..

Event Text Entries

[188486880] Additional information: date of event: between 12/16/2019 to 2/18/2020. Explanted, give date: not applicable as lens has not been explanted. (b)(4). Device evaluation: product testing could not be performed as the product was not returned. The reported complaint could not be verified. Manufacturing record review: the manufacturing records for the product were reviewed. The product was manufactured and released according to specifications. A search revealed that no similar complaints were received for this production order. 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

[188486881] It was reported that a zlb00 intraocular lens (iol) 20. 0 diopter was implanted in the patient? S right eye and a zkb00 20. 0 was implanted in the left eye. The patient is experiencing halos, blurry vision and starbursts. Per the patient, he was told at the doctor? S office before the surgeries that he? D have the eyesight of a 20-year old. However, after surgery, patient is experiencing halos, blurred vision and starbursts. He? S also having difficulty while driving at night. The sign posts look twice their actual size. The patient is not taking any eye drops. Thru follow-up the patient reported he had floaters prior to the implants. He still has floaters post implants but now the floaters are worse. He clarified, he is having the same symptoms in both eyes. The left eye is just worse. No further information was provided. This mdr will capture information for the right eye iol zlb00. The left eye is captured in a separate mdr.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 9614546-2020-00124
• MDR Report Key: 9836343
• Report Source: CONSUMER
• Date Received: 2020-03-16
• Date of Report: 2020-03-16
• Report Date: 2005-01-01
• Date Reported to FDA: 2005-01-01
• Date Reported to Mfgr: 2005-01-10
• Date Mfgr Received: 2020-02-18
• Date Added to Maude: 2020-03-16
• Event Key: 0
• Report Source Code: Manufacturer report
• Manufacturer Link: Y
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Health Professional: 0
• Initial Report to FDA: 0
• Report to FDA: 3
• Event Location: 3
• Manufacturer Contact: SOMYATA NAGPAL
• Manufacturer Street: 1700 EAST ST. ANDREW PLACE
• Manufacturer City: SANTA ANA CA 92705
• Manufacturer Country: US
• Manufacturer Postal: 92705
• Manufacturer Phone: 7142478200
• Manufacturer G1: JOHNSON & JOHNSON SURGICAL VISION, INC.
• Manufacturer Street: VAN SWIETENLAAN 5
• Manufacturer City: GRONINGEN 9728NX
• Manufacturer Country: NL
• Manufacturer Postal Code: 9728 NX
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Sequence Number: 1

• Brand Name: TECNIS 1 MULTIFOCAL
• Generic Name: MULTIFOCAL IOLS
• Product Code: MFK
• Date Received: 2020-03-16
• Model Number: ZLB00
• Catalog Number: ZLB00U0200
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: JOHNSON & JOHNSON SURGICAL VISION, INC.
• Manufacturer Address: 1700 E ST ANDREW PLACE SANTA ANA CA 92705 US 92705

Device Sequence Number: 101

• Product Code: ---
• Date Received: 2020-03-16
• Device Sequence No: 101
• Device Event Key: 0

Patients

Patient Number	Treatment	Outcome	Date
1	0		2020-03-16