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

Model Number ZCB00

Device Problems Failure to Unfold or Unwrap (1669); Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/05/2018

Event Type  malfunction  

Manufacturer Narrative

If implanted or explanted, give date: not applicable, as lens was removed/replaced in the initial surgery.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

It was reported that tecnis monofocal intraocular lens (model zcb00 +20.5 diopter) was removed and replaced in same surgical procedure because of unfolding issue.Lens of same model and same diopter was used as replacement for the patient.Reportedly there was no incision enlargement, no sutures, no patient injury.No further information provided.

Manufacturer Narrative

Device available for evaluation: yes.Returned to manufacturer on: 04/11/2018.Device returned to manufacturer: yes.Device evaluation: the product was returned to the manufacturing site for evaluation.Visual inspection with unaided eyes showed that the lens case contained no lens.Further examination also showed no lens contained in the cartridge, or in the bag.No testing can be performed since the lens is not physically returned.Manufacturing records review: the manufacturing records for the intraocular lens were reviewed.The product was manufactured and released according to specification.A search on complaints revealed that no other complaints were received for this production order number.Labeling review: the directions for use (dfu) was reviewed.The dfu adequately provides instructions and precautions along with warnings for the proper use and handling of the device.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.

• Brand Name: TECNIS 1-PIECE
• Type of Device: MONOFOCAL IOLS
• Manufacturer (Section D): JOHNSON & JOHNSON SURGICAL VISION, INC.; santa ana CA
• MDR Report Key: 7463279
• MDR Text Key: 107069813
• Report Number: 3011852734-2018-00063
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 05050474531727
• UDI-Public: (01)05050474531727(17)211116
• Combination Product (y/n): N
• PMA/PMN Number: P980040
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Type of Report: Initial,Followup
• Report Date: 06/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 11/16/2021
• Device Model Number: ZCB00
• Device Catalogue Number: ZCB0000205
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/11/2018
• Initial Date Manufacturer Received: 03/27/2018
• Initial Date FDA Received: 04/25/2018
• Supplement Dates Manufacturer Received: 05/10/2018
• Supplement Dates FDA Received: 06/07/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 67 YR