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 Code	Blurred Vision (2137)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event: unknown, not provided, but the best estimate date is between (b)(6) 2019 and (b)(6) 2020.If implanted, give date: unknown, information not provided.Two different dates (either (b)(6) 2019 or (b)(6) 2019) are indicated as implant dates, however the correct date has not been confirmed.Note: the device was manufactured at the (b)(4) site which has been closed.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 patient was not satisfied with the lens implanted in her eye.The patient states that her vision was blurry and not clear as her first eye.The eye affected could not be confirmed.The lens was explanted and replaced with another lens of same model zct150 but different diopter 23.0.The patient was temporarily impaired.The event was observed during the post operative examination.No further information was available.
Additional Manufacturer Narrative
Device evaluation: product testing could not be performed since the product was not returned for evaluation.Therefore, the reported issue could not be verified, and product quality deficiency could not be determined.Manufacturing records review: the manufacturing records for the product were reviewed.The product was manufactured and released according to specification.A search revealed that no additional complaint was received from this production order.Conclusion: as a result of the investigation, there is no indication of a product quality deficiency.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
Additional information: section b5: the eye affected of the patient was confirmed to be right eye.Section d6a: if implanted, give date: (b)(6), 2019.Correction: through follow-up corrected information was received concerning the lens that was explanted.The device details provided in the initial mdr were not appropriate for the right eye.The explanted lens serial number is (b)(6), therefore the following fields were updated accordingly; section d3: manufacturer: amo manufacturing netherlands van swietenlaan 5 groningen, netherlands 9728 nx.Section d4: model number: zct225.Section d4: catalog number: zct225u235.Section d4: serial number: (b)(6).Section d4: expiration date: jun 13, 2021.Section d4: unique identifier (udi) number: (b)(4).Section g1: manufacturer site: amo manufacturing netherlands van swietenlaan 5 groningen, netherlands 9728 nx.Section h4: device manufacture date: jun 13, 2017.All pertinent information available to johnson & 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 CA 9728 NX; NL 9728 NX
• MDR Report Key: 11988618
• Report Number: 2020664-2021-07043
• Device Sequence Number: 3165877
• Product Code: MJP
• UDI-Device Identifier: 05050474552173
• UDI-Public: (01)05050474552173(17)210731
• 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
• Device Implanted Year: 2019
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/23/2021

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: 06/13/2021
• Device Model Number: ZCT225
• Device Catalogue Number: ZCT225U235
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/14/2021
• Supplement Date Received by Manufacturer: 06/18/2021; 08/31/2021
• Initial Report FDA Received Date: 06/12/2021
• Supplement Report FDA Received Date: 07/17/2021; 09/23/2021
• 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
• Patient Age: 61 YR