MAUDE Adverse Event Report: JOHNSON & JOHNSON SURGICAL VISION TECNIS 1 MULTIFOCAL; MULTIFOCAL IOLS

Model Number	ZLB00
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Codes	Capsular Bag Tear (2639); Vitrectomy (2643); No Code Available (3191)
Date of Event	03/06/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that on day one post-op due to anterior capsule - posterior capsule rupture, the intraocular lens (iol) didn't stay centered as the capsular bag wasn¿t stable as the surgeon expected.Reportedly, the retinal doctor did a vitrectomy and explanted the intraocular lens (model zlb00, +18.5 diopter) in a secondary surgical procedure from the patient¿s operative eye.A competitor monofocal three-piece iol was used as a replacement lens.The patient was reported doing excellently when discharge.No further information was provided.
Additional Manufacturer Narrative
Device available for evaluation? yes.Returned to manufacturer on: 7/20/2018.Device returned to manufacturer? yes.Device evaluation: the device was received at the manufacturing site for investigation.Visual inspection shows the product was cut into two pieces, most probably to make explant possible.Considering the condition of the lens additional analysis is not possible.The complaint cannot be confirmed.Manufacturing record review: manufacturing record review of the production order and related document revealed that 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.Historical data analysis: the search in complaint history 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 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.

• Brand Name: TECNIS 1 MULTIFOCAL
• Common Device Name: MULTIFOCAL IOLS
• Manufacturer (Section D): JOHNSON & JOHNSON SURGICAL VISION; santa ana CA
• MDR Report Key: 7568919
• Report Number: 3011852734-2018-00095
• Device Sequence Number: 10807274
• Product Code: MFK
• UDI-Device Identifier: 05050474560642
• UDI-Public: (01)05050474560642(17)210611
• Combination Product (Y/N): Y
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/05/2018
• Report Date (Section F): 01/01/2005

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: 06/11/2021
• Device Model Number: ZLB00
• Device Catalogue Number: ZLB00U0185
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/20/2018
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 05/07/2018
• Supplement Date Received by Manufacturer: 08/14/2018
• Initial Report FDA Received Date: 06/05/2018
• Supplement Report FDA Received Date: 09/05/2018
• 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: 86 YR
• Date Report Sent to FDA: 01/01/2005