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

Model Number	ZCT150
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	01/08/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Weight and ethnicity: unknown, not provided.Manufacturer telephone number: (b)(4).All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
The customer reported that one of his patients will undergo a toric intraocular lens (iol) exchange.The lens was originally implanted on (b)(6) 2020, and the patient is now hyperopic and unhappy.The patient had prior myopic lasik on both eyes so selecting the best strength iol was more difficult.Preop keratometry (zeiss atlas) 37.32/ 38.65 x 007.Preop measurements were run on ascrs hill/wang/koch post refractive.At one-month post-operation on (b)(6) 2021: uncorrected visual acuity (ucva) = 20/70, refraction = +2.00 -1.00 x 040= 20/25.Marco opd-3 shows toric iol oriented at 20 degrees while the axis of astigmatism is 170 degrees.The patient was examined twice, and the surgeon suggested that he needs an iol exchange with +20.50 diopter zct150 oriented at 173 degrees.Through follow-up, it was learned that the patient underwent the iol exchange in his right eye.The replacement lens is the same model at a higher diopter, 20.5.Reportedly, the patient post-op course was benign and he now has an uncorrected distance vision of 20/25.He is very pleased with the results.
Additional Manufacturer Narrative
Device evaluation: product evaluation was not performed because the product remains implanted.The complaint issue reported could not be verified and no product deficiency could be identified.Manufacturing record review: the manufacturing process record was evaluated and revealed that the product was manufactured and released according to specifications.The search revealed one complaint which is coded for improperly loaded which is not related to this investigation.Therefore, no escalations are 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: LENS, INTRAOCULAR, TORIC OPTICS
• Manufacturer (Section D): AMO MANUFACTURING NETHERLANDS; van swietenlaan 5; groningen, groningen 9728 NX; NL 9728 NX
• MDR Report Key: 11792348
• Report Number: 9614546-2021-07154
• Device Sequence Number: 3949067
• Product Code: MJP
• UDI-Device Identifier: 05050474552098
• UDI-Public: (01)05050474552098(17)221012
• 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: 2020
• 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
• Report Date (Section B): 06/26/2021

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: 10/12/2022
• Device Model Number: ZCT150
• Device Catalogue Number: ZCT150U175
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/08/2021
• Supplement Date Received by Manufacturer: 06/14/2021
• Initial Report FDA Received Date: 05/07/2021
• Supplement Report FDA Received Date: 06/26/2021
• 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