MAUDE Adverse Event Report: AMO MANUFACTURING NETHERLANDS TECNIS IOL; MONOFOCAL IOLS

Model Number	DFW150
Medical Device Problem Codes	Break (1069); Operating System Becomes Nonfunctional (2996)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/16/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Telephone number: (b)(6).The intraocular lens (iol) is not returning for evaluation as it is discarded; therefore, a failure analysis of the complaint device cannot be completed.A review of the device history record, complaint trending, and risk documentation for this device will be performed.Upon completion of the review, if there is any further relevant information a supplemental medwatch will be filed.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that the technician rotated pre-load injector multiple times, then let the injector sit for approximately 5 minutes prior to implantation when it was noted the intraocular lens (iol) had a lens crack after inserting the iol into the right eye.The surgeon suspects the plunger cracked the iol.The lens was removed during the same procedure and was discarded.There was no vitrectomy, incision enlargement, or sutures required.Another johnson & johnson lens (same model and diopter) was implanted as a replacement.There was no patient injury.The patient is doing fine.No additional information was provided.

• Brand Name: TECNIS IOL
• Common Device Name: MONOFOCAL IOLS
• Manufacturer (Section D): AMO MANUFACTURING NETHERLANDS; van swietenlaan 5; groningen, groningen 9728 NX; NL 9728 NX
• MDR Report Key: 12169584
• Report Number: 9614546-2021-07273
• Device Sequence Number: 19821380
• Product Code: HQL
• UDI-Device Identifier: 05050474751316
• UDI-Public: (01)05050474751316(17)240413
• Combination Product (Y/N): N
• Initial Reporter State: UT
• 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): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/14/2021

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: 04/13/2024
• Device Model Number: DFW150
• Device Catalogue Number: DFW150U225
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/17/2021
• Initial Report FDA Received Date: 07/14/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1