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	Therapeutic Effects, Unexpected (2099); Blurred Vision (2137); Visual Impairment (2138)
Date of Event	09/25/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Telephone number: (b)(6).An attempt has been made to obtain missing information; however, no definitive response has been received.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that an intraocular lens (iol) was explanted from the left eye of a patient due to a residual refractive error, residual myopia and blurred visual acuity.The issues were observed during a post-operative examination.A replacement lens of the same model with different diopter (22.5) was used.There was no delay in procedure.There was no surgical intervention such as vitrectomy, incision enlargement or sutures required.The patient outcome was reported to be good, 20/20.There was no patient injury reported.No further information was provided.Pre-operative acuity: 20/50.Post-operative acuity: 20/25-1.
Additional Manufacturer Narrative
Corrected date: in review, it was noted that the section 'e1' was inadvertently not populated in the initial emdr report; therefore, the information has been captured in this supplemental emdr report.The following field was updated accordingly: section e1: establishment name: fishkind & bakewell md's additional information: section d9: device available for evaluation? yes; returned to manufacturer on: jan 25, 2021 section h3: device evaluated by manufacturer? yes device evaluation: the sample was received at the manufacturing site for 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 records review: the manufacturing process record was evaluated, and no nonconformity report was found during process related to the complaint issue reported.The product was manufactured and released according to specifications.A search in complaint system revealed that no other complaints have been received for this production order number.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: 11160454
• Report Number: 9614546-2021-07016
• Device Sequence Number: 13605135
• Product Code: HQL
• UDI-Device Identifier: 05050474657854
• UDI-Public: (01)05050474657854(17)241125
• 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): 03/01/2021

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: 11/25/2024
• Device Model Number: ZCU150
• Device Catalogue Number: ZCU150U230
• 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: 02/03/2021
• Initial Report FDA Received Date: 01/13/2021
• Supplement Report FDA Received Date: 03/02/2021
• 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