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

Model Number	ZA9003
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	10/28/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Device evaluation: the product returned was received at site.The haptic detached was observed.Viscoelastic residues and particles were in lens surface.The condition is consistent with the implanted/explanted process.Due the conditions of the returned sample product deficiency could not be determined.Manufacturing record review: the manufacturing process record was evaluated and revealed that the product was manufactured and released according to specifications.A search revealed that no additional investigation request were received from 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.
Event or Problem Description
It was reported that a za9003 intraocular lens (iol) when being inserted into the eye was removed.It was learned however, upon further follow-up that the iol was found to have dislocated during the post-op exam.It was confirmed that how the event occurred was that the patient was implanted the lens, went out of operating room (or) but had to go back into the or during the same day, because the doctor said that the lens dislocated.Patient went back into the or for lens removal.Patient post-op was uneventful, no injuries, no adverse events.No other information was available.
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 & JOHNSON SURGICAL VISION, INC.; 1700 e st andrew place; santa ana CA 92705
• MDR Report Key: 9770702
• Report Number: 2648035-2020-00195
• Device Sequence Number: 16874224
• Product Code: HQL
• UDI-Device Identifier: 05050474528970
• UDI-Public: (01)05050474528970(17)231024
• Combination Product (Y/N): Y
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: P990080
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other
• Type of Report: Initial,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: 10/24/2023
• Device Model Number: ZA9003
• Device Catalogue Number: ZA90030180
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/21/2020
• Was the Report Sent to FDA?: No
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 02/13/2020
• Supplement Date Received by Manufacturer: 10/25/2020
• Initial Report FDA Received Date: 02/28/2020
• Supplement Report FDA Received Date: 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: 38 YR
• Date Report Sent to FDA: 01/01/2005