MAUDE Adverse Event Report: ABBOTT MEDICAL OPTICS TECNIS 1 MULTIFOCAL; MULTIFOCAL IOLS

Model Number	ZKB00
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Halo (2227); No Code Available (3191)
Date of Event	10/12/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Age/date of birth: unknown, information not provided.Gender/sex: unknown, information not provided.Date of event: exact date is unknown, not provided, but the best estimate date is during 2017 up until (b)(6) 2018.If implanted, give date: unknown, information not provided.If explanted, give date: unknown, information not provided.(b)(4).All pertinent information available to abbott medical optics has been submitted.
Event or Problem Description
It was reported that a zkb00 23.5 diopter intraocular lens (iol) was implanted in the patient's operative eye.It was later explanted because the patient complained of halos.There was no incision enlargement or vitrectomy performed.Reportedly, the patient is okay and the lens was replaced with a non-amo lens.No additional information was provided.
Additional Manufacturer Narrative
Device evaluation: the product testing was not performed as the complaint device was not returned for evaluation.The reported complaint cannot be verified.Manufacturing record review: manufacturing records were reviewed and the device was manufactured according to specification.A search on complaints history revealed no similar complaints were received for this production order number to date.Labeling review: the directions for use (dfu) was reviewed.The dfu adequately provides instructions and precautions for the proper use and handling of the product.Conclusion: based on the investigation results there is no indication of a product quality deficiency.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
Per follow-up, patient started to experience symptoms on (b)(6) 2017.It was noted that patient had some retina edema, but was resolved on (b)(6) 2018.Patient has fully recovered and there was no patient injury.Age/date of birth: (b)(6) 1967.Gender/sex: female.Date of event: (b)(6) 2017.If implanted, give date: (b)(6) 2017.If explanted, give date: (b)(6) 2017.Patient code 3191 - retina edema.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

• Brand Name: TECNIS 1 MULTIFOCAL
• Common Device Name: MULTIFOCAL IOLS
• Manufacturer (Section D): ABBOTT MEDICAL OPTICS; santa ana CA 92705
• MDR Report Key: 7255674
• Report Number: 9614546-2018-00128
• Device Sequence Number: 16171047
• Product Code: MFK
• UDI-Device Identifier: 05050474560154
• UDI-Public: (01)05050474560154(17)200412
• 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: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/20/2018

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
• Operator of Device: Physician
• Device Expiration Date: 04/12/2020
• Device Model Number: ZKB00
• Device Catalogue Number: ZKB00U0235
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/11/2018
• Supplement Date Received by Manufacturer: 04/13/2018; 05/31/2018
• Initial Report FDA Received Date: 02/08/2018
• Supplement Report FDA Received Date: 04/28/2018; 06/20/2018
• 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
• Patient Age: 49 YR