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 Code Available (3191)
Date of Event	03/18/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Attempts have been made to obtain missing information; however, to date, no response has been received.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that upon insertion of the intraocular lens (iol) into the patient's left eye the haptic was bent.The doctor used the yamane technique to implant the iol.The iol was removed and replaced within the same procedure.There were no complications such as vitrectomy, sutures or incision enlargement and the procedure was completed successfully with a non j&j iol.Reportedly, the patient has recovered.No further information was provided.
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 (b)(4).
Additional Manufacturer Narrative
Corrected data: in the initial medwatch 2648035-2020-00432, we reported b1-adverse event because we considered the yamane technique as surgical intervention.However, the reported event was further reviewed by the johnson and johnson medical experts and they have determined that the yamane technique is not surgical intervention.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
Additional information: section d10: device available for evaluation: yes section d10: returned to manufacturer on: 6/4/2020 section h3: device returned to manufacturer: device evaluation: the product was returned to the manufacturing site for evaluation.The lens was observed with residues of viscoelastic related to the handling of the unit in a surgical procedure.Also, a haptic damaged was observed.The reported issue was verified but it could not be determined if the condition observed is related to manufacturing process since impacted lens was used in a surgical procedure.Manufacturing records review: the manufacturing records for the product were reviewed.The product was manufactured and released according to specifications.A search revealed that no other complaints were received for this production order.Conclusion: 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.

• Brand Name: TECNIS
• Common Device Name: MONOFOCAL IOLS
• Manufacturer (Section D): JOHNSON & JOHNSON SURGICAL VISION, INC.; 1700 e st andrew place; santa ana CA 92705
• MDR Report Key: 10121040
• Report Number: 2648035-2020-00432
• Device Sequence Number: 1762623
• Product Code: HQL
• UDI-Device Identifier: 05050474528864
• UDI-Public: (01)05050474528864(17)240524
• Combination Product (Y/N): Y
• Initial Reporter State: MN
• 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: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 10/30/2020
• 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: 05/24/2024
• Device Model Number: ZA9003
• Device Catalogue Number: ZA90030125
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/04/2020
• Was the Report Sent to FDA?: No
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 05/13/2020
• Supplement Date Received by Manufacturer: 06/12/2020; 06/20/2020; 10/25/2020
• Initial Report FDA Received Date: 06/04/2020
• Supplement Report FDA Received Date: 06/15/2020; 07/09/2020; 10/30/2020
• 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: 88 YR
• Date Report Sent to FDA: 01/01/2005