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

Model Number	ZCB00
Medical Device Problem Codes	Failure to Fold (1255); Failure to Unfold or Unwrap (1669)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/29/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information: patient age/date of birth: unknown as information was not provided.Patient gender: unknown as information was not provided.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 the intraocular lens (iol) had folding/unfolding issues and there was patient contact.No further information is available.
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:(b)(4).
Additional Manufacturer Narrative
Additional information was received, and the following fields were updated accordingly: section d-10: device available for evaluation: yes.Section d-10: returned to manufacturer on: 08/21/2020.Section h-3: device returned to manufacturer: yes.Device evaluation: the complaint lens was received loose inside its original folding carton.The original lens case was received as well.Visual inspection under magnification revealed what appeared to be viscoelastic residue on the optic body and haptics, and a small cut and lens damage on the lens (after cleaning the lens), which is consistent with a lens that was removed after patient contact.The complaint issue could not be confirmed, and no product deficiency could be 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 other complaints 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.The reported issue was not verified.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

• Brand Name: TECNIS 1-PIECE
• 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: 10474535
• Report Number: 2648035-2020-00652
• Device Sequence Number: 19535358
• Product Code: HQL
• UDI-Device Identifier: 05050474531604
• UDI-Public: (01)05050474531604(17)230406
• Combination Product (Y/N): Y
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/29/2020
• 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: 04/06/2023
• Device Model Number: ZCB00
• Device Catalogue Number: ZCB0000145
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/21/2020
• Was the Report Sent to FDA?: No
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 08/05/2020
• Supplement Date Received by Manufacturer: 09/03/2020; 10/25/2020
• Initial Report FDA Received Date: 08/31/2020
• Supplement Report FDA Received Date: 09/24/2020; 10/29/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 01/01/2005