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 Codes	Blurred Vision (2137); Visual Impairment (2138)
Date of Event	02/22/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Weight, ethnicity¿ unknown, not provided.Telephone number: (b)(6).All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that a tecnis toric intraocular lens (iol) was removed and replaced from the patient's operative eye in a secondary procedure due to hyperopic post-operative result, and blurry distance vision.The onset date was (b)(6) 2021 during the post-operative visit.An incision enlargement and sutures were required.The replacement lens is another toric lens.Visual acuity pre-operative was 20/20.Visual acuity post-operative was 20/25 -2 blurry.Manifest refraction (mrx) +0.75 = 20/20.No further information provided.
Additional Manufacturer Narrative
Additional information: section d9: device available for evaluation? yes.Section d9: date returned to manufacturer: (b)(6), 2021.Section h3: evaluated by manufacturer: yes.Device evaluation: visual inspection under magnification revealed viscoelastic residue on the optic body and haptics, which is consistent with a lens that was handled during explant.The lens was cleaned, and no cosmetic defects were observed.The complaint issue could not be confirmed, and no product deficiency could be identified.Manufacturing record review: the manufacturing records for the product were reviewed.The product was manufactured and released according to specifications.A search revealed that one additional complaint was received for this production order.However, it is not similar to the issues reported in this investigation.No further escalation is 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.

• 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: 11874843
• Report Number: 9614546-2021-07153
• Device Sequence Number: 1009305
• Product Code: HQL
• UDI-Device Identifier: 05050474657861
• UDI-Public: (01)05050474657861(17)250217
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/23/2021

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: 02/17/2025
• Device Model Number: ZCU150
• Device Catalogue Number: ZCU150U235
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/10/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/27/2021
• Supplement Date Received by Manufacturer: 07/11/2021
• Initial Report FDA Received Date: 05/25/2021
• Supplement Report FDA Received Date: 07/23/2021
• 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