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

Model Number	ZXT300
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Vitreous Floaters (1866); Inflammation (1932); Blurred Vision (2137)
Date of Event	11/28/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If explanted, give date: not applicable, as the lens remains implanted.Possible toxic anterior segment syndrome (tass).Attempts have been made to obtain missing information; however, to date, no response has been received.All pertinent information available to abbott medical optics has been submitted.
Event or Problem Description
It was reported that zxt300 16.0 diopter intraocular lens (iol) was implanted into the patient¿s right eye on (b)(6) 2017.One day post op the doctor notes lots of inflammation.The surgeon consulted with the retina specialist, and they both agreed that this was a case of toxic anterior segment syndrome (tass).The patient was reported as having a larger pupil and experiencing glare symptoms.In addition, there were several floaters in the right eye (od), maybe (ou) both eyes, big in size, and blurry vision.The condition¿s severity was noted as severe.Distance vision sc (without correction): 20/200 with increased steroid use.Second day post op since the affected area decreased and the patients vision became worse.No eye pain was experienced by the patient.Distance vision sc 20/200.Near vision od sc 20/200-1.Fourth day post op patient reported vision was a bit better, with no pain, tearing, or itching.There was some burning when applying eye drops.Distance vision sc 20/200.Near vision od 20/200-1.Two-week post-op the patient¿s vision was stable.The condition's severity was moderate.The patient was experiencing no eye pain.Distance vision sc 20/60-1 and near vision od sc 20/30 (j2) @ 12.Manifest refraction od -1.50 +0.50 x 140 (20/20-1).The patient was treated with prednisolone acetate 1%, ciprofloxacin 0.3%, durezol 0.05 % and neo-polyb-dexamethasone ointment.Also noted was that the lens was centered, axis 29 degrees and few cells in the vitreous.Tass is noted as resolving.Additional information was received from customer stating that there was no problem with the lens and that the product did not cause or contribute to the tass.No further information was provided.
Additional Manufacturer Narrative
Per external communication, explant of iol was not necessary.The patient is doing well.Last office visit was on (b)(6) 2018.At that time, patient no longer had any inflammation & vision was 20/20.She is no longer using any prescribed eye drops.Patient was advised to use artificial tears as needed & return yearly.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: 7202586
• Report Number: 9614546-2018-00069
• Device Sequence Number: 854205
• Product Code: POE
• UDI-Device Identifier: 05050474606302
• UDI-Public: (01)05050474606302(17)210804
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/25/2018

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: 08/04/2021
• Device Model Number: ZXT300
• Device Catalogue Number: ZXT300U160
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/19/2017
• Supplement Date Received by Manufacturer: 06/04/2018
• Initial Report FDA Received Date: 01/17/2018
• Supplement Report FDA Received Date: 06/25/2018
• 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: Required Intervention
• Patient Age: 51 YR