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

Model Number	ZCB00
Medical Device Problem Code	Positioning Problem (3009)
Health Effect - Clinical Codes	Intraocular Pressure Increased (1937); Capsular Bag Tear (2639); No Code Available (3191)
Date of Event	12/10/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If implanted, if explanted, give date: not applicable, as lens was removed/replaced during the same procedure.(b)(4).Device evaluation: on (b)(6) 2020 the original daisy wheel was received, but no lens was received.No product evaluation could be performed, because the complaint lens was not received.The complaint issue could not be confirmed, and no product deficiency could be identified.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 other complaints 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 zcb00 intraocular lens (iol) was inserted in the patient¿s left eye.But patient had high intraocular pressure that didn't allow the iol to sit correctly in the eye so it was removed and replaced.It was stated there was also a capsule tear, and the incision was enlarged.It was learned that 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-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: 9878863
• Report Number: 2648035-2020-00273
• Device Sequence Number: 2909815
• Product Code: HQL
• UDI-Device Identifier: 05050474531772
• UDI-Public: (01)05050474531772(17)230923
• Combination Product (Y/N): Y
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• 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
• 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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 09/23/2023
• Device Model Number: ZCB00
• Device Catalogue Number: ZCB0000230
• 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: 02/24/2020
• Supplement Date Received by Manufacturer: 10/25/2020
• Initial Report FDA Received Date: 03/25/2020
• Supplement Report FDA Received Date: 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
• Date Report Sent to FDA: 01/01/2005