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

Model Number	ZA9003
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	12/06/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As lens was removed/replaced during the same procedure.(b)(4).All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that a za9003, 17.5 diopter intraocular lens (iol), was removed and replaced during the initial surgery.When the lens was being inserted the surgeon noticed lens was hazy or translucent.Further information was provided and stated there was a film on the lens.The lens was immediately removed and replaced with another lens, same model and size.The incision was slightly enlarged and the patient is fine.There was no other information provided.
Additional Manufacturer Narrative
Device available for evaluation; returned to manufacturer on 1/22/2019.Device evaluation: a packaging box was received and there was a half of lens inside.The lens was observed under microscope and what appear to be viscoelastic residues, eye fluids and a pronounced mark was observed.There are no details about the film observed.Due the condition of the lens received the complaint could not be verified.A product quality deficiency could not be identified.Manufacturing records review: the manufacturing records for the device were reviewed.The product was manufactured and released according to specification.No non- conformance reports (nc) associated with the production order were found.The search in the complaint history revealed that no other complaint has been received for this production order number.Labeling review: the labeling review was completed.The directions for use (dfu) adequately provide instructions, precautions, along with warnings for the proper use and handling of the product.Conclusion: as a result of the investigation there is no indication of a product malfunction or 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
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
• Common Device Name: MONOFOCAL IOLS
• Manufacturer (Section D): JOHNSON AND JOHNSON SURGICAL VISION, INC.; 1700 east st. andrew place; santa ana CA 92705
• MDR Report Key: 8215671
• Report Number: 2648035-2019-00014
• Device Sequence Number: 19336883
• Product Code: HQL
• UDI-Device Identifier: 05050474528963
• UDI-Public: (01)05050474528963(17)230719
• Combination Product (Y/N): Y
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P990080
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,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?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/19/2023
• Device Model Number: ZA9003
• Device Catalogue Number: ZA90030175
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/22/2019
• Was the Report Sent to FDA?: No
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 12/06/2018
• Supplement Date Received by Manufacturer: 02/18/2019; 10/25/2020
• Initial Report FDA Received Date: 01/03/2019
• Supplement Report FDA Received Date: 03/14/2019; 11/06/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 66 YR
• Date Report Sent to FDA: 01/01/2005