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

Model Number	ZCU300
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/24/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If implanted, give date: not applicable, the lens was removed/replaced within the initial procedure.If explanted, give date: not applicable, the lens was removed/replaced within the initial procedure.Telephone number: (b)(6).The intraocular lens (iol) is not returning for evaluation as it was discarded by the customer; therefore, a failure analysis of the complaint device cannot be completed.A review of the device history record, and complaint trending 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 tecnis toric intraocular lens (iol) haptics would not sit properly upon insertion because the patient had zonules issue.Unplanned vitrectomy along with suture were used during the procedure.The replacement lens is a non-johnson and johnson lens.The customer also indicated that the lens was discarded.No further information provided.
Additional Manufacturer Narrative
Corrected data: initially, the customer reported that the patient had zonules and haptics would not sit properly.There is no indication that additional surgical intervention was required to preclude permanent damage/injury triggered by a j&j device and therefore should not have been initially reported.It was learned later that a duplicate report has been initiated for the same customer under the reported serial number.The second record included more details of the reported event; therefore, all relevant information has been submitted under medwatch 9614546-2021-07052.No further information will be submitted under the initial medwatch 9614546-2021-07005.

• 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: 11135355
• Report Number: 9614546-2021-07005
• Device Sequence Number: 19666819
• Product Code: HQL
• UDI-Device Identifier: 05050474660052
• UDI-Public: (01)05050474660052(17)250130
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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: company representative,health
• Initial Reporter Occupation: Physician
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date (Section B): 03/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 01/30/2025
• Device Model Number: ZCU300
• Device Catalogue Number: ZCU300U150
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 12/08/2020
• Supplement Date Received by Manufacturer: 02/02/2021
• Initial Report FDA Received Date: 01/07/2021
• Supplement Report FDA Received Date: 03/03/2021
• 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 CARTRIDGE, LOT CH03078
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 62 YR