MAUDE Adverse Event Report: ABBOTT MEDICAL OPTICS TECNIS SYMFONY TORIC; MULTIFOCAL IOLS

Model Number	ZXT150
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/23/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Remains implanted in the eye.All pertinent information available to abbott medical optics has been submitted.
Event or Problem Description
It was reported that a tecnis symfony multifocal intraocular lens (model zxt150 15.5 diopter) was inserted into the eye.After implantation, the doctor noticed a sticky substance adhered to the posterior surface of the lens which he tried to remove.However, he was unable to remove all of it as it was extremely difficult to remove.The remaining debris was left in the periphery of the lens.The doctor described the material as a gooey type substance.The account was been briefed again on the proper care and handling of the products before use.By the sales rep.As of right now, the doctor is going to leave the implant alone.The doctor stated he might attempt to yag the material at a later date.No further information provided.
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.

• Brand Name: TECNIS SYMFONY TORIC
• Common Device Name: MULTIFOCAL IOLS
• Manufacturer (Section D): ABBOTT MEDICAL OPTICS; santa ana CA
• MDR Report Key: 7287873
• Report Number: 9614546-2018-00173
• Device Sequence Number: 1824045
• Product Code: POE
• UDI-Device Identifier: 05050474605114
• UDI-Public: (01)05050474605114(17)210926
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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): 04/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Physician
• Device Expiration Date: 09/26/2021
• Device Model Number: ZXT150
• Device Catalogue Number: ZXT150U155
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/24/2018
• Supplement Date Received by Manufacturer: 04/10/2018
• Initial Report FDA Received Date: 02/21/2018
• Supplement Report FDA Received Date: 04/27/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 70 YR