MAUDE Adverse Event Report: AMO PUERTO RICO MFG. INC. TECNIS IOL; INTRAOCULAR LENS

Model Number	ZCU300
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Blurred Vision (2137); Visual Impairment (2138); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	04/16/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Weight and ethnicity: unknown, not provided.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that a zcu300 intraocular lens (iol) was explanted due to hyperopic results, blurry distance visual acuity (va).Patient noticed blurriness more after the other eye had cataract surgery and was crisp.Issues were noted during postop visit on (b)(6) 2021.The explanted lens was replaced with a new toric iol.There was an incision enlargement, but no sutures or vitrectomy were required.Outcome: 20/30 +2 blurry.Va pre-op: 20/50.Va post-op: 20/30 +2 blurry.Manifest refraction (mrx) +1.25- 0.50 x 75 20/20.No other information was provided.
Additional Manufacturer Narrative
Corrected data: upon further review, it was noted based on iol replacement information and product investigation results, the reported complaint is no longer considered a reportable event.The explanted intraocular lens (iol) was a zcu300 cylinder with 18.5 diopter and the replacement lens was zcu375 cylinder with 20.0 diopter and the product investigation lens diopter results confirmed that the production order was released within diopter specifications.Therefore, the provided information indicates a calculation issue and not a product problem.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 PUERTO RICO MFG. INC.; road 402 north, anasco ind. pk; anasco PR 00610
• MDR Report Key: 11943786
• Report Number: 2648035-2021-07947
• Device Sequence Number: 3958936
• Product Code: HQL
• UDI-Device Identifier: 05050474660120
• UDI-Public: (01)05050474660120(17)251016
• 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): 09/14/2021

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: 10/16/2025
• Device Model Number: ZCU300
• Device Catalogue Number: ZCU300U185
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/07/2021
• Supplement Date Received by Manufacturer: 08/18/2021
• Initial Report FDA Received Date: 06/05/2021
• Supplement Report FDA Received Date: 09/14/2021
• 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: 69 YR