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

Model Number Z9002

Device Problem Detachment Of Device Component (1104)

Patient Problem No Code Available (3191)

Event Date 05/16/2018

Event Type  Injury  

Manufacturer Narrative

If implanted, give date: not applicable, as lens was removed/replaced in the initial surgery.If explanted, give date: not applicable, as lens was removed/replaced in the initial surgery.(b)(4).All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Event Description

It was reported that the tecnis monofocal intraocular lens (model z9002, +18.0 diopter) was implanted and then the surgeon realized that the posterior capsule would not support the lens hence it was removed and replaced with an anterior chamber lens (non-johnson&johnson lens).Both the haptics were detached during the removal process.Additional information was received and it was learnt that during the removal of the lens, the incision was enlarged.No capsule tear and no other medical/surgical intervention was performed.The patient was reported doing good when discharged.No further information was provided.

Manufacturer Narrative

Device available for evaluation: yes, returned to manufacturer on: 07/20/2018.Device returned to manufacturer: yes.Device evaluation: the product was returned to the manufacturing site for evaluation.The lens was observed under microscope, and only half of the lens was returned to inspect, and the half that we receive had the haptic bent.The lens optic was observed cut in half and with residue.The complaint issue reported as haptic detached was not verified however due the condition of the lens received the complaint could not be related to the manufacturing process it could be related to the handling process; therefore, a product quality deficiency was not identified.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 CL
• Type of Device: MONOFOCAL IOLS
• Manufacturer (Section D): JOHNSON & JOHNSON SURGICAL VISION, INC.; santa ana CA
• Manufacturer (Section G): JOHNSON & JOHNSON SURGICAL VISION, INC.; road 402 north, km 4.2; anasco industrial park, pob 14; anasco PR 00610
• Manufacturer Contact: pam mcclain ; 1700 east st. andrew place; santa ana, CA 92705 ; 7142478243
• MDR Report Key: 7644797
• MDR Text Key: 112548097
• Report Number: 2648035-2018-00916
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 05050474530652
• UDI-Public: (01)05050474530652(17)220718
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: P880081
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/01/2005,08/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 07/18/2022
• Device Model Number: Z9002
• Device Catalogue Number: Z900200180
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/20/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Date Manufacturer Received: 08/03/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/18/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: PSCST30 CARTRIDGE, LOT UNKNOWN
• Patient Outcome(s): Required Intervention