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

Model Number	ZXR00
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	05/24/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).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 a zxr00 17.0 diopter intraocular lens (iol) was implanted into the patient's operative eye.It was later explanted due to a malfunction.The lens was replaced with model zcb00, but the diopter was not reported.No additional information was provided.
Additional Manufacturer Narrative
Additional information received reported the patient was a female with date of birth (b)(6).Also, the reason for explant was because the patient was not happy with the lens and wanted a monofocal lens.There was no other visual issues known.Also, the implant date was (b)(6) 2017, and the explant date was (b)(6) 2017.There was no incision enlargement or vitrectomy when removing the lens.Reportedly, the diopter of the replacement lens was 17.0.The surgeon was reported as dr.Douglas grayson and the patient's outcome after surgery is good.No additional information was provided.Age/date of birth: (b)(6).Gender/sex: female.If implanted, give date: (b)(6) 2017.If explanted, give date: (b)(6) 2017.Device available for evaluation?: yes, returned to manufacturer on 10/23/2017.Initial reporter name: dr.(b)(6).Health professional: yes.Occupation: physician.Device evaluation: the product was returned to the manufacturing site for evaluation.The product is inspected by a qualified inspector using a 12x magnification.It can be seen that the lens is cut, there is a scratch on the posterior side and it is damaged on the posterior side.The product was most likely damaged due to explant.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 were received for this production order number.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
• Common Device Name: MULTIFOCAL IOLS
• Manufacturer (Section D): ABBOTT MEDICAL OPTICS; santa ana CA 92705
• MDR Report Key: 6970660
• Report Number: 9614546-2017-01022
• Device Sequence Number: 69130
• Product Code: POE
• UDI-Device Identifier: 05050474579033
• UDI-Public: (01)05050474579033(17)220301
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/22/2017

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?: No
• Operator of Device: Physician
• Device Expiration Date: 03/01/2022
• Device Model Number: ZXR00
• Device Catalogue Number: ZXR00U0170
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/23/2017
• Initial Date Received by Manufacturer: 09/28/2017
• Supplement Date Received by Manufacturer: 10/26/2017
• Initial Report FDA Received Date: 10/23/2017
• Supplement Report FDA Received Date: 11/22/2017
• 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: Required Intervention
• Patient Age: 65 YR