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

Model Number ZCB00

Device Problems Break (1069); Difficult to Fold, Unfold or Collapse (1254); Difficult to Insert (1316)

Patient Problem No Code Available (3191)

Event Date 11/12/2018

Event Type  Injury  

Manufacturer Narrative

Implant and explant dates: not applicable, as the lens was only partially implanted/inserted and removed.(b)(4).Device evaluation: the product testing could not be performed as the product was not returned.The reported complaint cannot be confirmed.Manufacturing record review: the manufacturing process record was evaluated and no deviation was found during process related to the complaint issue reported.There was no discrepancy found during the mrr (manufacturing record review).The product was manufactured and released according to specifications.A search revealed that no additional complaints were received for this production order.Labeling review: the directions for use (dfu) was reviewed.The dfu adequately provides instructions and precautions for the proper use and handling of the product.Conclusion: based on the investigation results there is no indication of a product quality deficiency.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Event Description

It was reported that a zcb00 intraocular lens (iol) was partially inserted into the patient right eye using an emeraldc30 cartridge.The haptic came out wrong, the lens got stuck and the haptic was bent.There was an incision enlargement performed.A loading and folding issue was also reported.No additional information was provided.

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
• Type of Device: MONOFOCAL IOLS
• Manufacturer (Section D): JOHNSON & JOHNSON SURGICAL VISION, INC.; santa ana CA 92705
• MDR Report Key: 8149007
• MDR Text Key: 129874099
• Report Number: 3011852734-2018-00229
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 05050474531765
• UDI-Public: (01)05050474531765(17)220522
• Combination Product (y/n): Y
• PMA/PMN Number: P980040
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 01/01/2005,11/05/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 05/22/2022
• Device Model Number: ZCB00
• Device Catalogue Number: ZCB0000225
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Report Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Initial Date Manufacturer Received: 11/12/2018
• Initial Date FDA Received: 12/10/2018
• Supplement Dates Manufacturer Received: 10/25/2020
• Supplement Dates FDA Received: 11/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: EMERALD CARTRIDGE, LOT CC09090
• Patient Outcome(s): Required Intervention
• Patient Age: 82 YR