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

Model Number	ZCU150
Medical Device Problem Code	Device Contaminated During Manufacture or Shipping (2969)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/27/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The lens remains implanted.Mfr site telephone number: (b)(6).The intraocular lens (iol) is not returning for evaluation as it remains implanted; 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 initially reported that the surgeon noticed an intraocular lens (iol) had a plastic fiber stuck on the lens before insertion.The patient is fine and another johnson & johnson lens (same model) was implanted as a replacement.Through follow-up, it was learned there was patient contact, and once the lens was implanted, there was a visible clear plastic on the lens.It appeared to be similar to a piece of the cartridge.The plastic fiber piece was removed immediately.The lens remains implanted.There was no report of any medical/surgical intervention required.No further information is available.
Additional Manufacturer Narrative
Additional information: section d9: device available for evaluation? yes.Section d9: returned to manufacturer on: 7/21/2021.Section h3: device evaluated by manufacturer¿ yes.Device evaluation: complaint lens and foreign material was not received.A j&j cartridge tip and cartridge tip tray were received.No complaint lens or foreign material were received, therefore, no product evaluation could be performed or the sample could not be forwarded to eag laboratories for further analysis.The returned cartridge tip and tray were inspected for foreign material, but no "plastic fiber" as described by the customer could be identified.The complaint issue could not be confirmed and no product deficiency could be identified.Manufacturing record review: the manufacturing records for the intraocular lens were reviewed.The product was manufactured according to specifications.The search revealed that no similar complaint for this production order number has been received.Conclusion: as a result of the investigation there is no indication of a product quality deficiency and the reported issue could not be confirmed.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
Section d10: in the initial report model of cartridge used was provided as unknown, however, the model cartridge is 1mtec30 and injector used was a (platinum).Lot number remains unknown as they were not provided.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
• Manufacturer Contact: somyata nagpal ; van swietenlaan 5; groningen, groningen 9728 -NX ; NL 9728 NX
• MDR Report Key: 11897928
• Report Number: 9614546-2021-07184
• Device Sequence Number: 19754218
• Product Code: HQL
• UDI-Device Identifier: 05050474657854
• UDI-Public: (01)05050474657854(17)241008
• 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
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/16/2022

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: 10/08/2024
• Device Model Number: ZCU150
• Device Catalogue Number: ZCU150U230
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/21/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/07/2021
• Supplement Date Received by Manufacturer: 09/14/2021; 02/09/2022
• Initial Report FDA Received Date: 05/27/2021
• Supplement Report FDA Received Date: 09/21/2021; 02/16/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/08/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 1MTEC LOT #:UNKNOWN; CARTRIDGE, MODEL AND LOT# UNKNOWN
• Patient Sex: Unknown