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

Model Number	ZCU300
Medical Device Problem Code	Application Program Problem: Dose Calculation Error (1189)
Health Effect - Clinical Code	Discomfort (2330)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Weight and ethnicity: unknown, information not provided.Date of event: unknown, not provided, but the best estimate date is between 11/5/2020-2/18/2021.(b)(6).(b)(4).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) was explanted from patient's left eye due to diopter miss and the patient was not happy.The original lens diopter was 16.5 and the replacement lens have the diopter 19.0.No other medical intervention was required.
Additional Manufacturer Narrative
Correction and additional information: b5: additional: subsequent follow up information received confirms that the diopter miss of the intraocular lens was due to the calculation miss by the surgeon.The patient is doing well post-operation and is happy.Upon reviewing the complaint folder, it has been determined that the diopter miss of the intraocular lens was due to the calculation miss by the surgeon.The information provided does not represent a product problem, but an error by the surgeon in calculation.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 9614546-2021-07097.G8: correction: in review, of medwatch 9614546-2021-07097 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 ; NL
• MDR Report Key: 11494748
• Report Number: 9614546-2021-07097
• Device Sequence Number: 19819757
• Product Code: HQL
• UDI-Device Identifier: 05050474660083
• UDI-Public: (01)05050474660083(17)241126
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• 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?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 11/26/2024
• Device Model Number: ZCU300
• Device Catalogue Number: ZCU300U165
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/18/2021
• Supplement Date Received by Manufacturer: 03/24/2021
• Initial Report FDA Received Date: 03/16/2021
• 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
• Outcome Attributed to Adverse Event: Required Intervention