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

Model Number ZCB00V

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Unspecified Infection (1930); Inflammation (1932)

Event Date 10/27/2019

Event Type  Injury  

Manufacturer Narrative

If explanted; give date: n/a (not applicable).The lens remains implanted.(b)(6).Pma/510k: this report is being filed on an international device; tecnis optiblue itec preloaded 1-piece iol, model zcb00v that has a similar device, tecnis 1-piece iol model zcb00 which is distributed in the united states under pma p980040.Device evaluation: the product testing could not be performed as the product was not returned (the lens remains implanted).Two pictures were provided by the customer which were evaluated with the following results: it was observed a lens implanted in patient eye, making it visually impossible to identify through the photo the condition reported.Based on the photos provided, it is not possible to confirm the defect reported, since have poor resolution and high magnification.Based on the evidence observed and since the lens is not available for a thoroughly evaluation, the complaint issue reported could not be verified.Product deficiency could not be determined.Manufacturing records review: the manufacturing process record was evaluated and no deviation was found during process related to the complaint issue reported.There were no discrepancies found during the mrr (manufacturing record review).The product was manufactured and released according to specifications.A search in complaint system revealed no additional investigation requests for this production order number.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 Description

It was reported that the doctor found the white cells on the intraocular lens (iol), model zcb00v 23.5 diopters (5) days after implanted the lens in the right eye (od) of a male patient.It was indicated that there was no complication during surgery, that there was no corneal edema and no current diseases involved.The visual acuity (va) for the right eye (od) is 6/9.It was reported that the doctor has not given any treatment and that the va is good and it is not a posterior capsule opacification (pco).No additional information was provided.

Manufacturer Narrative

Additional information: in follow-up the question was asked to please confirm if the case was infection/inflammation.The response received clarified that there was inflammation.No further information provided.All pertinent information available to johnson & johnson surgical vision, inc.At the time of this report has been submitted.

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 OPTIBLUE 1-PIECE
• Type of Device: MONOFOCAL IOLS
• Manufacturer (Section D): JOHNSON & JOHNSON SURGICAL VISION, INC.; 1700 e st andrew place; santa ana CA 92705
• MDR Report Key: 9353125
• MDR Text Key: 167546261
• Report Number: 2648035-2019-01233
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 05050474546813
• UDI-Public: (01)05050474546813(17)240124
• Combination Product (y/n): Y
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,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?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/24/2024
• Device Model Number: ZCB00V
• Device Catalogue Number: ZCB00V0235
• 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: 10/27/2019
• Initial Date FDA Received: 11/21/2019
• Supplement Dates Manufacturer Received: 11/22/2019; 10/25/2020
• Supplement Dates FDA Received: 12/19/2019; 11/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other