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

Model Number	ZCT225
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event: unknown, not provided, but the best estimate date is between (b)(6) 2017.(b)(4).An attempt has 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 zct225 22.0 diopter intraocular lens (iol) was implanted on (b)(6) 2017.It was later explanted on (b)(6) 2017 because the lens was coming out of the capsular bag, possibly due to the patient rubbing the operative eye.The replacement lens was a non-amo lens.No additional information was provided.
Additional Manufacturer Narrative
Additional information received reported that it is unknown if the patient rubbed their operative eye.At the one-day post-operative visit the patient was fine, but at the one-week post-operative visit on (b)(6) 2017, the doctor noticed the lens had dislocated behind the pupil and was affecting the patient's vision.Also, the patient is a female with date of birth is (b)(6), and with an operative eye of the right eye (od).There was no incision enlargement, vitrectomy, or sutures used.The patient was seen for a post-operative visit on (b)(6) 2017 and is doing fine.No additional information was provided.Age/date of birth: (b)(6).Gender/sex: female.All pertinent information available to abbott medical optics has been submitted.
Additional Manufacturer Narrative
Device evaluation: product testing could not be performed because the product was not returned.The reported issue could not be verified.Manufacturing records review: the manufacturing records for the product were reviewed.The product was manufactured and released according to specifications.A complaint history search revealed that no similar complaints were received for this production order number.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 johnson and johnson surgical vision, inc.Has been submitted.

• Brand Name: TECNIS
• Common Device Name: TORIC IOLS
• Manufacturer (Section D): ABBOTT MEDICAL OPTICS; santa ana CA 92705
• MDR Report Key: 7012475
• Report Number: 9614546-2017-01078
• Device Sequence Number: 19171941
• Product Code: HQL
• UDI-Device Identifier: 05050474552777
• UDI-Public: (01)05050474552777(17)200429
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/28/2018

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?: Yes
• Operator of Device: Physician
• Device Expiration Date: 04/29/2020
• Device Model Number: ZCT225
• Device Catalogue Number: ZCT225U220
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/13/2017
• Supplement Date Received by Manufacturer: 11/08/2017; 02/27/2018
• Initial Report FDA Received Date: 11/09/2017
• Supplement Report FDA Received Date: 12/06/2017; 03/28/2018
• 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