MAUDE Adverse Event Report: JOHNSON AND JOHNSON SURGICAL VISION, INC. TECNIS 1 MULTIFOCAL; MULTIFOCAL IOLS

Model Number	ZLB00
Medical Device Problem Code	Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Codes	Blurred Vision (2137); Halo (2227); Vitrectomy (2643)
Date of Event	03/29/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If implanted; give date: unknown/not provided however, an approximate date of (b)(6) 2018 was provided.(b)(4).All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that a doctor is exchanging a zlb00 intraocular lens (iol), as during the post op exam, an iol malfunction (patient having visual issues) along with an incorrect biometry was reported.Patient visual issues included decreased vision, shadows, starbursts, along with blurred vision, halos, a -2.00 in the left eye (os).The best corrected visual acuity (bcva) pre-op was -20/40, bcva post-op was 20/70.Follow up provides the lens was replaced with a zlb00 26.5 diopter lens.The doctor had to enlarge the incision, put in 3 sutures and also did an anterior vitrectomy.The patient was noted to be fine post-op.No other information was provided.
Additional Manufacturer Narrative
Through follow up the complete implant date was provided.If implanted: (b)(6) 2018.The product testing could not be performed as the product was not returned.The reported complaint cannot be confirmed.The manufacturing records for the device were reviewed.The product was manufactured and released according to specification.The search in the complaint history revealed that no another complaint has been received for this production order number.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.
Additional Manufacturer Narrative
Additional information: device available for evaluation ¿ yes, returned to manufacturer on 12/7/2018.Device returned to manufacturer ¿ yes.Device evaluation: visual inspection with the unaided eye showed that the product is cut in pieces, most probably to make explant possible.Considering the condition of the lens additional analysis is not possible.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
This correction mdr is being submitted to address inaccurate information in section f on the xml version of the previous submission caused by a software glitch in the transmission process.The internal non-conformance numbers for this software issue are (b)(4) and capa-010215.

• Brand Name: TECNIS 1 MULTIFOCAL
• Common Device Name: MULTIFOCAL IOLS
• Manufacturer (Section D): JOHNSON AND JOHNSON SURGICAL VISION, INC.; 1700 east st. andrew place; santa ana CA 92705
• MDR Report Key: 8057706
• Report Number: 9614546-2018-01068
• Device Sequence Number: 1747864
• Product Code: MFK
• UDI-Device Identifier: 05050474560840
• UDI-Public: (01)05050474560840(17)200404
• Combination Product (Y/N): Y
• Initial Reporter State: VA
• 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,Followup,Followup
• Report Date (Section B): 11/04/2020
• 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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 04/04/2020
• Device Model Number: ZLB00
• Device Catalogue Number: ZLB00U0285
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/07/2018
• Was the Report Sent to FDA?: No
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 10/15/2018
• Supplement Date Received by Manufacturer: 11/14/2018; 01/30/2019; 10/25/2020
• Initial Report FDA Received Date: 11/09/2018
• Supplement Report FDA Received Date: 12/12/2018; 02/25/2019; 11/04/2020
• 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: 79 YR
• Date Report Sent to FDA: 01/01/2005