MAUDE Adverse Event Report: JOHNSON & JOHNSON SURGICAL VISION, INC. TECNIS; MONOFOCAL IOLS

Model Number	ZA9003
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	12/13/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If implanted; give date: n/a (not applicable).The intraocular lens was not implanted.If explanted; give date: n/a (not applicable).The intraocular lens was not implanted.(b)(6).All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that one of the haptics of the za9003 tecnis monofocal iol (intraocular lens) was observed to be broken when removing the lens from the packaging.No additional information was provided.
Additional Manufacturer Narrative
Device available for evaluation: yes, returned to manufacturer on: 1/29/2019, device returned to manufacturer: yes, device evaluation: the device was returned to the manufacturer for evaluation.The sample was received inside the lens case in the packaging box.The lens was observed under microscope and no damages were observed in the optic zone.The haptics were observed positioned and without damages.The complaint was not verified in the return sample.No product quality deficiency was identified.Manufacturing records review: the manufacturing records for the product was reviewed.The product was manufactured and released according to specification.Historical data analysis: a search in complaint history revealed no other complaint has been received for this production order number.Labeling review: the labeling review was completed and revealed that the directions for use (dfu) provide the customer with proper usage instructions and guidelines.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
In review, it was noted that the incorrect date was inadvertently entered in section (date of report) of the supplemental mdr report#1; therefore, the date has been corrected in this supplemental report.The following field was updated accordingly: 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 nr-0148919 and capa-010215.

• Brand Name: TECNIS
• Common Device Name: MONOFOCAL IOLS
• Manufacturer (Section D): JOHNSON & JOHNSON SURGICAL VISION, INC.; santa ana CA 92705
• MDR Report Key: 8230714
• Report Number: 2648035-2019-00046
• Device Sequence Number: 1887438
• Product Code: HQL
• UDI-Device Identifier: 05050474529090
• UDI-Public: (01)05050474529090(17)230606
• Combination Product (Y/N): Y
• Initial Reporter Country: ES
• PMA/510(K) Number: P990080
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 11/06/2020
• 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?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/06/2023
• Device Model Number: ZA9003
• Device Catalogue Number: ZA90030240
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/29/2019
• Was the Report Sent to FDA?: No
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 12/14/2018
• Supplement Date Received by Manufacturer: 02/14/2019; 03/06/2019; 10/25/2020
• Initial Report FDA Received Date: 01/09/2019
• Supplement Report FDA Received Date: 03/06/2019; 03/07/2019; 11/06/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 01/01/2005