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

Model Number	ZCT225
Medical Device Problem Code	Failure to Eject (4010)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	05/14/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional information: patient age/date of birth: unknown as information was not provided.If implanted; give date: not applicable as the iol was not implanted.If explanted; give date: not applicable as the iol was not implanted.(b)(4).All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported zct225 18.0 diopter intraocular lens (iol) model was stuck in the cartridge and it would not advance or remove.There was no patient contact, the patient left the surgery center without having a lens inserted into the patient¿s ocular sinister (left eye), and a second surgery is required.It was also reported outcome significantly interferes with activities of daily life.No additional information was provided to johnson & johnson surgical vision.
Additional Manufacturer Narrative
Additional information: section d-10: device available for evaluation: yes.Section d-10: returned to manufacturer on: 08/07/2019.Section h-3: device returned to manufacturer: yes.Device evaluation: the product was received in a zip lock bag.Visual inspection of the return sample shows the product is stuck in cartridge.The complaint can be confirmed.Considering the condition of the return additional analysis is not possible.A product deficiency cannot be confirmed.Manufacturing records review: the manufacturing records for the product were reviewed, the product was manufactured and released according to specification.Historical data analysis: a search revealed that no similar complaints for this production order number have been received.Conclusion: as a result, of the investigation there is no indication of a product malfunction or product quality deficiency.The reported issue was not verified.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.H3 other text : placeholder.
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: TORIC IOLS
• Manufacturer (Section D): JOHNSON & JOHNSON SURGICAL VISION, INC.; 1700 e st andrew place; santa ana CA 92705
• MDR Report Key: 8848948
• Report Number: 9614546-2019-00677
• Device Sequence Number: 2230284
• Product Code: HQL
• UDI-Device Identifier: 05050474552692
• UDI-Public: (01)05050474552692(17)211114
• Combination Product (Y/N): Y
• Initial Reporter State: MT
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/11/2020
• 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: 11/14/2021
• Device Model Number: ZCT225
• Device Catalogue Number: ZCT225U180
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/07/2019
• Was the Report Sent to FDA?: No
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 07/01/2019
• Supplement Date Received by Manufacturer: 09/06/2019; 10/25/2020
• Initial Report FDA Received Date: 07/31/2019
• Supplement Report FDA Received Date: 09/12/2019; 11/12/2020
• 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: 1MTEC30 CARTRIDGE, LOT NUMBER CB39355
• Outcome Attributed to Adverse Event: Required Intervention
• Date Report Sent to FDA: 01/01/2005