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

Model Number	Z9002
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	07/15/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information: if implanted; give date: not applicable as the iol was not implanted.If explanted; give date: not applicable as the iol was not implanted.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported z9002 19.5 diopter intraocular lens (iol) the haptic was bent and kinked in the cartridge.New design has a wider thread and advances too quickly causing it to rotate and kink the haptic in the cartridge.There is no patient contact, no serious patient injury, no medical complications, and there was no surgical intervention.No additional information was provided to johnson & johnson surgical vision.
Additional Manufacturer Narrative
Device available for evaluation: yes, returned to manufacturer on: 08/23/2019.Device returned to manufacturer: yes.Device evaluation: the z9002 lens was received in the original packaged.Visual inspection using microscope magnification was performed.One lens haptic was observed distorted/bent, confirming the reported issue.Evidence of viscoelastic residues was detected on the unit.The lens was handled and used.There is no evidence to suggest that the complaint sample has been affected by the manufacturing process.No product deficiency was identified.Manufacturing records review: the manufacturing records for the product were reviewed, the product was manufactured and released according to specification.Historical data analysis: a search revealed that no additional investigation request for this production order number have been received.Conclusion: as a result, of the investigation there is no indication of a product malfunction or product quality deficiency.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Additional 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 CL
• Common Device Name: MONOFOCAL IOLS
• Manufacturer (Section D): JOHNSON & JOHNSON SURGICAL VISION, INC.; 1700 e st andrew place; santa ana CA 92705
• MDR Report Key: 8892873
• Report Number: 2648035-2019-00879
• Device Sequence Number: 1658619
• Product Code: HQL
• UDI-Device Identifier: 05050474530683
• UDI-Public: (01)05050474530683(17)240221
• Combination Product (Y/N): Y
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P880081
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/11/2020
• Report Date (Section F): 01/01/2005

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
• Operator of Device: Health Professional
• Device Expiration Date: 02/21/2024
• Device Model Number: Z9002
• Device Catalogue Number: Z900200195
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/23/2019
• Was the Report Sent to FDA?: No
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 07/19/2019
• Supplement Date Received by Manufacturer: 09/09/2019; 10/25/2020
• Initial Report FDA Received Date: 08/14/2019
• Supplement Report FDA Received Date: 09/19/2019; 11/12/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: PSCST30 CARTRIDGE LOT NUMBER CE04908.; PSCST30 CARTRIDGE LOT NUMBER CE04908.
• Date Report Sent to FDA: 01/01/2005