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

Model Number	ZLB00
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Flashers (1864); Blurred Vision (2137); Halo (2227)
Date of Event	05/06/2015
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional information: patient weight: unknown/no information.All pertinent information available to johnson & johnson surgical vision, inc., has been submitted.
Event or Problem Description
Received report indicating that the intraocular lens (iol), model zlb00, was explanted from the patient¿s right eye due to experiencing halos, starburst and poor vision.The doctor clarified that the patient had frontal arcuate incisions overcorrecting his astigmatism.The replacement lens was another johnson and johnson lens of different model and diopter.There was no patient injury reported and no further intervention was required.Reportedly the patient outcome is excellent.No further information was provided.
Additional Manufacturer Narrative
Additional information: device evaluation: product testing could not be performed as the product was not returned.The reported event could not be verified, and no product deficiency could be identified.Manufacturing records review: the manufacturing records for the product were reviewed.The product was manufactured and released according to specifications.A search revealed another complaint was for this production order but unrelated to this investigation.Conclusion: based on the investigation, no product deficiency was identified.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
Additional information: section d9: device available for evaluation? yes.Section d9: date returned to manufacturer: nov 11, 2021.Additional information: device evaluation: the complaint lens was received in a specimen cup.No additional product was received as part of this return.A cup containing the lens was received with writing on it.It states od on (b)(6) 2021.Visual inspection under magnification revealed viscoelastic residue on the optic body and haptics and that the lens was received cut in half, which is consistent with a lens that was handled during explant.Based on the return condition of the lens, no further product evaluation could be performed.A product quality deficiency could not be determined.Conclusion: as a result of the investigation there is no indication of a product quality deficiency and the reported issue could not be verified.Regarding the additional information on the specimen cup that states od (right eye) on (b)(6) 2021.The information implies the explant date is on (b)(6) 2021 which differs from the explant date initially provided by the customer on (b)(6) 2021.Follow-up was done to get clarification.However no response has been received.If a response is received clarifying the correct date is on (b)(6) 2021 then a follow-up report will be submitted to the fda.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
Corrected data: the customer provided follow-up information explaining that the initial explant date they provided of (b)(6).2021 was incorrect.Reported in medwatch md-0005283.The correct explant date is (b)(6).2021.Therefore, this supplemental filing is to correct section d6b.Section d6b if explanted; give date: (b)(6).2021.All pertinent information available to johnson & johnson surgical vision, inc., has been submitted.

• Brand Name: TECNIS IOL
• Common Device Name: LENS, MULTIFOCAL INTRAOCULAR
• Manufacturer (Section D): AMO MANUFACTURING NETHERLANDS; van swietenlaan 5; groningen, groningen 9728 NX; NL 9728 NX
• Manufacturer Contact: somyata nagpal ; 1700 e st andrew place; santa ana, CA 92705 ; 7142478552
• MDR Report Key: 12558607
• Report Number: 2020664-2021-07419
• Device Sequence Number: 4306677
• Product Code: MFK
• UDI-Device Identifier: 05050474560642
• UDI-Public: (01)05050474560642(17)190310
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2021
• 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,Followup
• Report Date (Section B): 01/26/2022

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: 03/10/2019
• Device Model Number: ZLB00
• Device Catalogue Number: ZLB00U0185
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/11/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 09/09/2021
• Supplement Date Received by Manufacturer: 10/05/2021; 12/28/2021; 01/24/2022
• Initial Report FDA Received Date: 09/30/2021
• Supplement Report FDA Received Date: 10/18/2021; 01/07/2022; 01/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/10/2015
• 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 Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White