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

Model Number	ZCU300
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Blurred Vision (2137)
Date of Event	12/01/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient weight and ethnicity: unknown/no information.Date of event: exact date is unknown, not provided.Best estimate is between (b)(6) 2020 - (b)(6) 2020.(b)(6).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
Received report indicating the intraocular lens (iol) was exchanged due to residual astigmatism observed during a post-op examination.The patient experienced blurry visual acuity (va).Va pre-operative 20/30, va post-operative 20/40.Reportedly, there was no vitrectomy, sutures or incision enlargement required.No further information was provided.
Additional Manufacturer Narrative
Corrected data: in the initial report section b2 was not completed.This field has now been indicated as required intervention to prevent permanent impairment/damage.Additional information: customer provided additional information.As a result of this additional information the following fields have been updated accordingly; section b3, date of event: is (b)(6) 2020.Section e1, initial reporter is physician's name is (b)(6).Section e2, health professional? yes.Initially reported as no.Section e3, occupation: physician.Initially reported as blank.The customer also explained that the patient outcome is 20/25.And the replacement lens is model zcu150 diopter 21.5 diopter lens.No further information was provided.Device evaluation: visual inspection under magnification revealed viscoelastic residue on the optic body and haptics and that the lens was received cut in pieces (not all pieces received), 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.The complaint issue could not be confirmed, 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 that no other complaints have been received for this production order.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.

• Brand Name: TECNIS IOL
• Common Device Name: INTRAOCULAR LENS
• Manufacturer (Section D): AMO MANUFACTURING NETHERLANDS; van swietenlaan 5; groningen 9728 NX; NL 9728 NX
• MDR Report Key: 11160087
• Report Number: 9614546-2021-07014
• Device Sequence Number: 13605134
• Product Code: HQL
• UDI-Device Identifier: 05050474660151
• UDI-Public: (01)05050474660151(17)241118
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/16/2021

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: 11/18/2024
• Device Model Number: ZCU300
• Device Catalogue Number: ZCU300U200
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/25/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 12/15/2020
• Supplement Date Received by Manufacturer: 01/18/2021
• Initial Report FDA Received Date: 01/13/2021
• Supplement Report FDA Received Date: 02/16/2021
• 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: 71 YR