MAUDE Adverse Event Report: AMO PUERTO RICO MFG. INC. TECNIS IOL; INTRAOCULAR LENS

Model Number	ZCU300
Medical Device Problem Codes	Use of Device Problem (1670); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/21/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If implanted, give date: not applicable, as lens was removed/ replaced in the initial surgery.If explanted, give date: not applicable, as lens was removed/replaced in the initial surgery.Attempts have been made to obtain missing information; however, to date, no response has been received.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that the doctor was not happy upon the insertion of the intraocular lens (iol).The surgery was successfully completed with a backup lens of the same model and diopter.The event was observed when inserting into the eye.No further information is available.
Additional Manufacturer Narrative
Corrected data: additional information received from the surgery center revealed that the reason for doctor being unhappy was due to loading issue of the lens and there was patient contact only with the cartridge tip.There was no patient injury and no medical intervention was required.The procedure was completed successfully using another lens of same model and diopter.Upon reviewing the complaint folder, it has been determined as there was patient contact only with the cartridge tip and the reason for doctor being unhappy was due to the reported loading issue, the event this time is not considered a reportable event.Therefore, no further information will be submitted under medwatch 2648035-2021-07320.Additional information: section h6: health effect - impact code: 2199 - no health consequences or impact.Section h6: medical device problem code: 1670 - use of device problem.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 PUERTO RICO MFG. INC.; road 402 north, anasco ind. pk; anasco PR 00610
• MDR Report Key: 11398395
• Report Number: 2648035-2021-07320
• Device Sequence Number: 3381825
• Product Code: HQL
• UDI-Device Identifier: 05050474660168
• UDI-Public: (01)05050474660168(17)250930
• Combination Product (Y/N): N
• Initial Reporter State: NH
• 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: health professional,user faci
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/29/2021

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: 09/30/2025
• Device Model Number: ZCU300
• Device Catalogue Number: ZCU300U205
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/05/2021
• Supplement Date Received by Manufacturer: 03/01/2021
• Initial Report FDA Received Date: 03/02/2021
• Supplement Report FDA Received Date: 03/29/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1