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

Model Number	ZXR00
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event: unknown, not provided.If explanted; give date: not applicable (n/a) the lens remains implanted.(b)(4).The intraocular lens (iol) is not returning for evaluation as it remains implanted; therefore, a failure analysis of the complaint device cannot be completed.A review of the device history record, labeling, complaint trending, and risk documentation for this device will be performed.Upon completion of the review, if there is any further relevant information a supplemental medwatch will be filed.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that the patient was implanted with zxr00 27.0 diopter intraocular lens (iol) and experienced an unexpected post-op outcome.It was noted that pre-op the patient was +3.75.Target was plano and post-op is -3.00.The patient isn¿t unhappy with the result but wants to understand the miss before the second eye surgery.An exact date was not provided.Per medical review follow-up it was noted that the patient's unusual eye, short axial length and steep keratometry which can cause uncertainty in predicting the estimated lens position.The physician was not sure if the refraction acquired was pushing-plus, so it was advised to repeat carefully a pushing-plus manual refraction to determine the amount of myopic error.It was also discussed evaluating the capsular bag distension, plateau iris, malignant glaucoma, as these finding can cause the lens to sit further anteriorly as well.The physician will be seeing the patient again for further evaluation.No additional information provided.
Additional Manufacturer Narrative
Based on new information received, jjsv representative spoken to the customer; the doctor just had a few questions regarding lens constants and targeting for this patient¿s second eye.The doctor will also likely be utilizing optiwave refractive analysis (ora) for the second eye.In regards to the first eye with the unexpected outcome, the doctor stated that the manifest refraction is now -1.75 ds and best corrected visual acuity (bcva) of 20/20 as opposed to the -3.00 ds initially reported.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 other 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.

• Brand Name: TECNIS SYMFONY
• Common Device Name: MULTIFOCAL IOLS
• Manufacturer (Section D): JOHNSON & JOHNSON SURGICAL VISION, INC.; santa ana CA 92705
• MDR Report Key: 7528589
• Report Number: 3011852734-2018-00083
• Device Sequence Number: 16609959
• Product Code: HQL
• UDI-Device Identifier: 05050474579231
• UDI-Public: (01)05050474579231(17)230110
• Combination Product (Y/N): Y
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/11/2018
• Report Date (Section F): 01/01/2005

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: 01/10/2023
• Device Model Number: ZXR00
• Device Catalogue Number: ZXR00U0270
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 04/20/2018
• Supplement Date Received by Manufacturer: 06/18/2018
• Initial Report FDA Received Date: 05/20/2018
• Supplement Report FDA Received Date: 07/11/2018
• 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
• Date Report Sent to FDA: 01/01/2005