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

Model Number	ZXT225
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
There was no indication that the lens has been explanted.(b)(4).All pertinent information available to the manufacturer has been submitted.
Event or Problem Description
It was reported that a patient had an unexpected postop result one week after implantation of a zxt225 28.5 diopter intraocular lens (iol).The patient is about 20/60 for distance and j1 for reading at one/two weeks post op.The patient is +2.25 myopic with -0.25 cylinder.All the tests concluded that the lens implant to be a 28.5 diopter lens which was verified with the ora, ocular response analyzer.The physician noted that he would like to do the lens exchange as soon as possible to minimize the risk of lens/capsule fibrosis.Further information notes the doctor believes the implanted iol was likely mislabeled.He is planning to proceed with an iol exchange next week.No further information was provided.
Additional Manufacturer Narrative
Additional information received reported that the doctor performed the following tests, but could not determine the cause of the unexpected post-operative results: ocular response analyzer (ora), a scan, and iol master (biometry).Also, the doctor decided to leave the lens implanted and did not explant the lens.He instead sent the patient to a specialist to perform photorefractive keratectomy (prk) about a month ago.The patient is doing fine.No additional information was provided.If explanted, give date: not applicable, as the lens remains implanted.All pertinent information available to abbott medical optics has been submitted.
Additional Manufacturer Narrative
Device evaluation: the product was not returned to the manufacturing site.Therefore, product testing could not be performed and the customer¿s reported complaint could not be verified.Manufacturing records review: the manufacturing records for the intraocular lens were reviewed.The product was manufactured and released according to specification.A search on complaints revealed that no similar complaints have been received for this production order number.Labeling review: the directions for use (dfu) was reviewed.The dfu adequately provides instructions and precautions along with warnings for the proper use and handling of the device.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 abbott medical optics 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: 6430471
• Report Number: 9614546-2017-00231
• Device Sequence Number: 551171
• Product Code: POE
• UDI-Device Identifier: 05050474605961
• UDI-Public: (01)05050474605961(17)211108
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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,Followup
• Report Date (Section B): 10/29/2017

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?: Yes
• Operator of Device: Physician
• Device Expiration Date: 11/08/2021
• Device Model Number: ZXT225
• Device Catalogue Number: ZXT225U285
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/24/2017
• Supplement Date Received by Manufacturer: 09/13/2017; 10/04/2017
• Initial Report FDA Received Date: 03/23/2017
• Supplement Report FDA Received Date: 10/09/2017; 10/29/2017
• 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