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

Model Number ZCT225

Device Problem Optical Decentration (1360)

Patient Problems Vitrectomy (2643); No Code Available (3191)

Event Date 08/09/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).All pertinent information available to abbott medical optics has been submitted.

Event Description

It was reported that a zct225 21.5 diopter intraocular lens (iol) was implanted into the right eye (od) on (b)(6)2017.It was then explanted the next day, (b)(6)2017, because of poor centration and poor vision.Pre-operative visual acuity was 20/200 and post-operative visual acuity was also 20/200.There was an incision enlargement and vitrectomy performed.The patient's vision improved after surgery with a post-operative visual acuity of 20/50.The replacement lens was the same diopter but a different model, a za9003 lens.No additional information was provided.

Manufacturer Narrative

Device evaluation: product testing could not be performed because the product was not returned.The reported complaint was not verified.Manufacturing records review: the manufacturing records for the product were reviewed.The product was manufactured and released according to specifications.A search revealed that no similar complaints for this order number have been received.Labeling review: the directions for use (dfu) were reviewed.The dfu provide the customer with proper usage instructions and guidelines.Conclusion: as a result of the investigation, there is no indication of a product quality deficiency.All pertinent information available to abbott medical optics has been submitted.

• Brand Name: TECNIS
• Type of Device: TORIC 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: 6843877
• MDR Text Key: 84933516
• Report Number: 9614546-2017-00838
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 05050474538788
• UDI-Public: (01)05050474538788(17)200226
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: P980040
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/05/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 02/26/2020
• Device Model Number: ZCT225
• Device Catalogue Number: ZCT2250215
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/20/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/26/2016
• 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: 66 YR