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

Model Number ZCB00

Device Problem Failure to Deliver (2338)

Patient Problem No Code Available (3191)

Event Date 07/20/2020

Event Type  Injury  

Manufacturer Narrative

Age/date of birth: unknown/ not provided.Sex/gender: unknown/ not provided.If implanted, give date: n/a (not applicable).The intraocular lens was not implanted.If explanted, give date: n/a (not applicable).The intraocular lens was not implanted; therefore, not explanted.(b)(4).Attempts have been made to obtain missing information; however, to date, no response has been received.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Event Description

The account reported that they had difficulties loading the intraocular lens (iol) and tried three (3) times to load the lens.It was indicated that the doctor always makes small incision.He attempted to insert the lens and enlarged the incision.A new replacement lens was inserted without difficulty.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 (b)(4) and capa-010215.

Manufacturer Narrative

Device evaluation: the product testing could not be performed as the product was not returned for evaluation.The reported complaint cannot be confirmed.Manufacturing record review: the manufacturing process record was evaluated, and no deviation or nonconformance was found during process related to the complaint issue reported.The product was manufactured and released according to specifications.A search in complaint system revealed that no other complaints have been received 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 and johnson surgical vision has been submitted.

• Brand Name: TECNIS 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: 10405711
• MDR Text Key: 206849721
• Report Number: 2648035-2020-00613
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 05050474531819
• UDI-Public: (01)05050474531819(17)240306
• 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,Followup
• Report Date: 01/01/2005,10/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/13/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/06/2024
• Device Model Number: ZCB00
• Device Catalogue Number: ZCB0000250
• 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
• Date Manufacturer Received: 10/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention