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

Model Number ZXT100

Device Problems Inadequacy of Device Shape and/or Size (1583); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Code Available (3191)

Event Date 11/14/2017

Event Type  Injury  

Manufacturer Narrative

If implanted, give date: unknown, information not provided.If explanted, give date: not applicable, as the lens remains implanted.However, the doctor is thinking of explanting the lens.(b)(6).(b)(4).All pertinent information available to abbott medical optics has been submitted.

Event Description

It was reported that a zxt100 28.5 diopter intraocular lens (iol) was implanted in the patient's left eye (od), but the doctor is thinking of explanting the lens because the patient is dissatisfied with their vision post-operatively and the astigmatism is too high.Pre-operative: vcc = sph.+3.0/cyl.-0.75/a 173°=1.0.Post-operative: vsc = 0.4; vcc=sph.-0.5/cyl.-1.50/a 81°.Vcc: visual acuity corrected.Vsc: visual acuity without correction.No additional information was provided.

Manufacturer Narrative

Additional information: additional information received reported the lens was explanted on (b)(6) 2017, and replaced with a zxt100 27.0, smaller diopter intraocular lens (iol).There was no complications during surgery.The patient's vision was at a distance of 1.0 and near was 0.6 at the one week post-operative appointment on (b)(6) 2017.Furthermore, on (b)(6) 2017 the patient had a vision of 1.0 in the distance and in the near.The patient and doctor are very happy with the results.No additional information was provided.The following sections have been updated: if explanted, give date: (b)(6) 2017.(b)(4).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 product was 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
• Type of Device: MULTIFOCAL IOLS
• Manufacturer (Section D): ABBOTT MEDICAL OPTICS; santa ana CA 92705
• Manufacturer (Section G): ABBOTT MEDICAL OPTICS INC.; van swietenlaan 5; groningen 9728 NX; NL 9728 NX
• Manufacturer Contact: pam mcclain ; 1700 east st. andrew place; santa ana, CA 92705 ; 7142478243
• MDR Report Key: 7146850
• MDR Text Key: 95789647
• Report Number: 9614546-2017-01261
• Device Sequence Number: 1
• Product Code: POE
• UDI-Device Identifier: 05050474577510
• UDI-Public: (01)05050474577510(17)220622
• Combination Product (y/n): N
• PMA/PMN Number: P980040
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/16/2018

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
• Device Operator: Physician
• Device Expiration Date: 06/22/2022
• Device Model Number: ZXT100
• Device Catalogue Number: ZXT100I285
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/28/2017
• Initial Date FDA Received: 12/26/2017
• Supplement Dates Manufacturer Received: 12/17/2017
• Supplement Dates FDA Received: 01/16/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/22/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 46 YR