MAUDE Adverse Event Report: JOHNSON & JOHNSON SURGICAL VISION, INC. TECNIS 1-PIECE; MONOFOCAL IOLS

Model Number	ZCB00
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Visual Impairment (2138); No Code Available (3191)
Date of Event	04/03/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that tecnis monofocal intraocular lens (model zcb00 +12.0 diopter) was scheduled to be explanted from patient¿s left eye in secondary surgical procedure because of patient experiencing hyperopic surprise impacting the patient with decreased visual acuity.Additional information was received, and it was learnt that explant took place as scheduled.Suture was placed to close the wound.There was no incision enlargement, and no vitrectomy required.Reportedly lens with same model and higher diopter was used as replacement for the patient.Patient was in good condition at discharge.Visual acuity pre-op (pre-initial implant): 20/40.Visual acuity post-op (post-initial implant): best corrected visual acuity (bcva 20/25+.No further information provided.
Additional Manufacturer Narrative
Device evaluation: product testing could not be performed since the product was not returned for evaluation.The customer's reported complaint could not be verified.Manufacturing records review: the manufacturing records for the product were reviewed.The product was manufactured and released according to specification.A search revealed no additional investigation request for this production order number has been received.Labeling review: the directions for use (dfu) were reviewed.The dfu adequately provides instructions and precautions along with warnings for the proper use and handling of the device.Conclusion: as a result of the investigation, there is no indication of a product quality deficiency.All pertinent information available to johnson and 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 1-PIECE
• 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: 8572002
• Report Number: 2648035-2019-00524
• Device Sequence Number: 2267793
• Product Code: HQL
• UDI-Device Identifier: 05050474531550
• UDI-Public: (01)05050474531550(17)220309
• Combination Product (Y/N): Y
• Initial Reporter Country: CA
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• 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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 03/09/2022
• Device Model Number: ZCB00
• Device Catalogue Number: ZCB0000120
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 04/03/2019
• Supplement Date Received by Manufacturer: 05/10/2019; 10/25/2020
• Initial Report FDA Received Date: 05/02/2019
• Supplement Report FDA Received Date: 06/06/2019; 11/12/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 73 YR
• Date Report Sent to FDA: 01/01/2005