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

Model Number	ZCT225
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/25/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If implanted, give date: not applicable, as lens was not implanted.If explanted, give date: not applicable.All pertinent information available to johnson & johnson surgical vision, inc has been submitted.
Event or Problem Description
Customer reported that after insertion of the intraocular lens (iol), the surgeon asked for a vitrector.Patient left aphakic per surgeon.It was learned that the (pre-op visual acuity) w/correction = 20/80, pinhole 20/70-1.Postop (b)(6) 2021 w/o correction 20 @ 3 feet, pinhole 2400.No patient injury.No additional surgical/medical intervention performed or planned.The issue has not significantly affected the patient's ability to perform activities of daily life.Patient is doing very good.No other information was provided.
Additional Manufacturer Narrative
Device evaluation: product evaluation was not performed because the product has not been returned.The complaint issue reported could not be verified and no product deficiency could be identified.Manufacturing record review: the manufacturing process record was evaluated and revealed that the product was manufactured and released according to specifications.The search revealed one complaint file found.The complaint issue cannot be confirmed related to manufacturing; therefore, no escalations are required.Conclusion: as a result of the investigation there is no indication of a product quality deficiency and the reported issue could not be verified.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
Corrected data: section h6: as part of an internal review of our mdrs it was identified that the code(s) 4581 provided on the initial report needs to be removed as it should not have been indicated in the initial report.Also for health effect clinical code 4582 should be added.Field below updated: section h6: health effect clinical code: 4582 (captures no patient involvement / no harm).All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.

• Brand Name: TECNIS IOL
• Common Device Name: LENS, INTRAOCULAR, TORIC OPTICS
• 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: 12090062
• Report Number: 9614546-2021-07254
• Device Sequence Number: 11752051
• Product Code: MJP
• UDI-Device Identifier: 05050474552678
• UDI-Public: (01)05050474552678(17)220926
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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 Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/21/2022

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: 09/26/2022
• Device Model Number: ZCT225
• Device Catalogue Number: ZCT225U170
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/01/2021
• Supplement Date Received by Manufacturer: 08/25/2021; 08/26/2022
• Initial Report FDA Received Date: 06/30/2021
• Supplement Report FDA Received Date: 09/08/2021; 09/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/26/2018
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 82 YR
• Patient Sex: Male
• Patient Weight: 79 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White