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

Model Number	ZCU300
Medical Device Problem Code	Unstable (1667)
Health Effect - Clinical Codes	Blurred Vision (2137); Visual Impairment (2138)
Date of Event	04/29/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(6).All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that the patient's distance vision was blurry and it appeared doubled after the implantation of zcu300 model intraocular lens (iol) in the patient's right eye.At the 1 month post operative (op) visit, patient presented with diagnostic refraction (drx) +1.75 -1.25 x 55.It was noticed that iol had rotated 20 degrees off axis and the iol was rotated back to the correct axis on (b)(6) 2021.Post rotation of the lens, the patient outcome was drx +1.75 -0.75 x 93, which was a hyperopic result and needed the lens to be explanted from patient's eye in a different surgical procedure.The incision was enlarged to explant the lens from patient's eye, but no vitrectomy or sutures were required.The replacement lens used is another toric lens of zcu225 model and 14.0 diopter.Patient/ user outcome: visual acuity pre-operative: 20/30 -2, visual acuity post-operative: 20/30 -2 doubled, visual acuity: +1.75-1.25 x 55 20/20 -1 pre rotation + explant of lens.Patient was 20/20 uncorrected distance vision (ucdv) at both day 1 and week 1 post explant and with replacement lens.No further information was available.
Additional Manufacturer Narrative
Section d9: device available for evaluation? yes; section d9: returned to manufacturer on: 7/21/2021; section h3: device evaluated by manufacturer? yes.Device evaluation: the product was returned to the manufacturing site for evaluation.Visual inspection under magnification revealed, that the lens was received with viscoelastic residue on the optic body and haptics.Which is consistent with a lens that was handled, during explant.The lens was cleaned and visually inspected.No cosmetic issues were identified.The complaint issue could not be confirmed.And no product deficiency could be identified.Manufacturing record review: the manufacturing records for the intraocular lens were reviewed.The product was manufactured and released according to specification.The search revealed, no additional complaints from this production order number has been received.Conclusion: as a result of the investigation, there is no indication of a product quality deficiency.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: 12229772
• Report Number: 9614546-2021-07302
• Device Sequence Number: 3357430
• Product Code: HQL
• UDI-Device Identifier: 05050474659995
• UDI-Public: (01)05050474659995(17)250226
• 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): 08/24/2021

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/26/2025
• Device Model Number: ZCU300
• Device Catalogue Number: ZCU300U120
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/21/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/29/2021
• Supplement Date Received by Manufacturer: 08/13/2021
• Initial Report FDA Received Date: 07/27/2021
• Supplement Report FDA Received Date: 08/24/2021
• 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 Weight: 116