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

Model Number	ZA9003
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/13/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If implanted; give date: n/a (not applicable).The intraocular lens was removed and replaced during the same procedure.If explanted; give date: n/a (not applicable).The intraocular lens was removed and replaced during the same procedure.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported intraocular lens (iol) model za9003 with 12.5 dipoter was inserted into the patient's operative eye and the haptic broke off.The iol was removed by cutting the lens in half.There was no patient injury and no medical intervention was required.The procedure was completed successfully using the same model and diopter size lens as a replacement.The patient outcome was reported as doing well.No additional information was provided to johnson & johnson surgical vision.
Additional Manufacturer Narrative
Device evaluation: the product was not returned to the manufacturing site.Therefore, product testing could not be performed and the customer¿s reported complaint could not be verified.Manufacturing records review: the manufacturing records for the product was reviewed.The product was manufactured and released according to specification.A search on complaints revealed that no additional 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 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.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
Additional information this report will capture device evaluation.Device available for evaluation: yes.Returned to manufacturer: 11/29/2018.Device returned to manufacturer: yes device evaluation: the za9003 lens was received in its original package.Visual inspection using magnification was performed to the returned sample: loose fibers/particles were observed on lens related the handling of the unit.Residues of viscoelastic material was observed on lens.The lens was observed with a large cut.One of the haptic was observed detached.The detached haptic piece was not returned.The other haptic was observed damaged/distorted.The condition in which the sample returned is consistent with a lens that was implanted and removed.Conclusion: as a result of the investigation there is no indication of a product malfunction or product quality deficiency.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; 1700 e. st. andrew place; santa ana CA 92705
• MDR Report Key: 7972045
• Report Number: 2648035-2018-01337
• Device Sequence Number: 11076559
• Product Code: HQL
• UDI-Device Identifier: 05050474528864
• UDI-Public: (01)05050474528864(17)200208
• Combination Product (Y/N): Y
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P990080
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 11/03/2020
• 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: 02/08/2020
• Device Model Number: ZA9003
• Device Catalogue Number: ZA90030125
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/29/2018
• Was the Report Sent to FDA?: No
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 09/18/2018
• Supplement Date Received by Manufacturer: 10/30/2018; 12/03/2018; 10/25/2020
• Initial Report FDA Received Date: 10/16/2018
• Supplement Report FDA Received Date: 11/21/2018; 12/17/2018; 11/03/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNKNOWN CARTRIDGE MODEL AND LOT NUMBER.
• Date Report Sent to FDA: 01/01/2005