MAUDE Adverse Event Report: JOHNSON & JOHNSON SURGICAL VISION, INC. TECNIS 1 MULTIFOCAL; MULTIFOCAL IOLS

Model Number	ZMB00
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Blurred Vision (2137); Visual Impairment (2138)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event: unknown, not provided, but the best estimate date is between (b)(6) 2012 and (b)(6) 2018.The lens remains implanted.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that a zmb00 18.5 diopter intraocular lens (iol) was implanted in the patient's right eye (od) on (b)(6) 2012.Post-operatively, the patient complained of not being able to read anymore and blurry vision.Reportedly, there is no plan to explant the lens, but the patient was prescribed eyeglasses.No additional information was provided.The patient had bilateral lenses implanted.This report will capture the lens implanted in the patient's right eye.A separate report will be filed for the left eye.
Additional Manufacturer Narrative
Correction: in follow up#2, date received by manufacturer was not correct as it should have indicated the following: april 16, 2018.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
Device evaluation: the product testing could not be performed as the product was not returned.The reported complaint cannot be confirmed.Manufacturing record review: the manufacturing process record was evaluated and no deviation was found during process related to the complaint issue reported.There was no discrepancy found during the mrr (manufacturing record review).The product was manufactured and released according to the specifications.A search revealed that no similar complaints were received from this production order.Labeling review: the directions for use (dfu) was reviewed.The dfu adequately provides instructions and precautions for the proper use and handling of the product.Conclusion: based on the investigation results there is no indication of a product quality deficiency.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
Additional information: additional patient data stating that patient did have irregular corneas on both eyes (ou) pre-operatively, which is contraindicated for a tecnis multifocal (tmf) lens.In 2013 (1 year post-op), the patient did have 1+ posterior capsular opacification (pco) and 2+ pco on the right eye (od) and left eye (os) respectively, which likely contributed to the decreased visual acuity.No other post-op data was provided.All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.

• Brand Name: TECNIS 1 MULTIFOCAL
• Common Device Name: MULTIFOCAL IOLS
• Manufacturer (Section D): JOHNSON & JOHNSON SURGICAL VISION, INC.; santa ana CA 92705
• MDR Report Key: 7351577
• Report Number: 9614546-2018-00261
• Device Sequence Number: 19106016
• Product Code: MFK
• UDI-Device Identifier: 05050474535596
• UDI-Public: (01)05050474535596(17)140928
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 06/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Physician
• Device Expiration Date: 09/28/2014
• Device Model Number: ZMB00
• Device Catalogue Number: ZMB00U0185
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/20/2018
• Supplement Date Received by Manufacturer: 03/12/2018; 04/13/2018; 05/15/2018
• Initial Report FDA Received Date: 03/19/2018
• Supplement Report FDA Received Date: 04/09/2018; 05/12/2018; 06/08/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other