MAUDE Adverse Event Report: AMO MANUFACTURING NETHERLANDS TECNIS IOL; INTRAOCULAR LENS

Model Number	ZCU150
Medical Device Problem Codes	Use of Device Problem (1670); Inaccurate Delivery (2339); Difficult to Advance (2920)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/29/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If implanted, give date: not applicable, as lens was not implanted.If explanted, give date: not applicable, as lens was not implanted.(b)(6).All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that the intraocular lens (iol) had loading issue and the lens injected when injector was only partially inserted in the patient's left eye.The lens was partially inserted and was removed and replaced with another lens of same model.The event was observed while inserting into the eye.The outcome does not significantly interferes with activities of daily life.No further information is available.
Additional Manufacturer Narrative
B5: additional: subsequent follow up information received from the surgery center confirms that the issue of part of lens getting stuck in the incision was due to surgeon error that the tip of the cartridge slipped during implantation.There was no patient injury.Section h6: medical device problem code: 2339 - inaccurate delivery.Section h6: medical device problem code: 1670 - use of device problem.Upon reviewing the complaint folder, it has been determined that the issue of part of lens getting stuck in the incision was due to surgeon error that the tip of the cartridge slipped during implantation.There was no patient injury.As the event was due to use error and not due to product issue, based on our reportable criteria, this report is no longer a reportable event.Therefore, an emdr is required to state that no further follow ups will be sent out under medwatch 9614546-2021-07080.G8: correction: in review, of medwatch 9614546-2021-07080 and per new information received, this event has been assessed not reportable.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

• Brand Name: TECNIS IOL
• Common Device Name: INTRAOCULAR LENS
• Manufacturer (Section D): AMO MANUFACTURING NETHERLANDS; van swietenlaan 5; groningen, groningen 9728 NX; NL 9728 NX
• MDR Report Key: 11398608
• Report Number: 9614546-2021-07080
• Device Sequence Number: 14295981
• Product Code: HQL
• UDI-Device Identifier: 05050474657830
• UDI-Public: (01)05050474657830(17)240916
• Combination Product (Y/N): N
• Initial Reporter State: ND
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/14/2021

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: 09/16/2024
• Device Model Number: ZCU150
• Device Catalogue Number: ZCU150U220
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/04/2021
• Supplement Date Received by Manufacturer: 03/19/2021
• Initial Report FDA Received Date: 03/02/2021
• Supplement Report FDA Received Date: 04/14/2021
• 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: 1MTEC30_CH13663; (B)(4)
• Patient Age: 61 YR