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

Model Number	ZCU150
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Visual Impairment (2138)
Date of Event	03/09/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Information unknown/not provided.Phone number: (b)(6).Attempts have been made to obtain the missing information; however, to date, the information has not been received.All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that a patient who was status post (s/p) radial keratotomy (rk) & laser vision correction (lvc), underwent an intraocular lens (iol) explant on the right eye due to poor post-op result.The patient¿s symptom was noticed 1-day post operation.A replacement lens of different model and diopter, zcu225 (+20.0 d) was used.There was no patient injury reported.The patient outcome post-op was reported to be 20/40 at 1-day po still following.No further information was provided.
Additional Manufacturer Narrative
Device evaluation: the product testing could not be performed as the product was not returned.The reported complaint cannot be confirmed.Manufacturing record evaluation: the manufacturing records for the intraocular lens were reviewed.The product was manufactured and released according to specifications.A search in the complaint system revealed that no other complaints have been received for this production order number.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 and johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
Corrected data, upon further review, it was realized that the event should not have been reported since the patient had a history of radial keratotomy (rk) procedure which would require a different lens power to be calculated/used and as reported event was not due to the lens product problem or malfunction.Therefore, the event is no longer reportable and no further information will be provided under this manufacturer report number (b)(4).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
• MDR Report Key: 12047331
• Report Number: 9614546-2021-07252
• Device Sequence Number: 3427244
• Product Code: HQL
• UDI-Device Identifier: 05050474657830
• UDI-Public: (01)05050474657830(17)241004
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• 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,Followup
• Report Date (Section B): 09/05/2021

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: 10/04/2024
• Device Model Number: ZCU150
• Device Catalogue Number: ZCU150U220
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/24/2021
• Supplement Date Received by Manufacturer: 07/21/2021; 08/09/2021
• Initial Report FDA Received Date: 06/23/2021
• Supplement Report FDA Received Date: 07/27/2021; 09/05/2021
• 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