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

Model Number	DFR00V
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Visual Impairment (2138)
Date of Event	09/08/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pt info: information unknown/not provided.Date of event: exact date unknown/not provided.Best estimate date is (b)(6) 2021.Attempts have been made to obtain missing information; however, to date, no 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 patient's right eye due to residual refractive error.A replacement lens of the same model but different diopter (22.0) was used.There were no surgical and/or medical interventions required.Reportedly the patient is doing well post-operative (op) and no patient injury was reported.No other information was provided.
Additional Manufacturer Narrative
Additional information received from the account indicated that the patient is a caucasian female and that the patient's symptom first noticed on (b)(6) 2021.The following fields were updated accordingly: section a3: gender: female.Section a5: race: white (caucasian).Section b3: date of event: (b)(6) 2021.Section h3: device evaluated by manufacturer: yes.Device evaluation: the product testing could not be performed as the product has not been returned for evaluation.The reported complaint cannot be confirmed.Manufacturing records review: the manufacturing records review was performed, and no nonconformity report was found as part of this manufacturing records review.The product was manufactured and released according to specifications.A search in complaint system revealed that two similar complaints have been received for this production order number; however, the reported issues were not confirmed based on investigation results.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
• Manufacturer Contact: somyata nagpal ; 1700 e st andrew place; santa ana, CA 92705 ; 7142478552
• MDR Report Key: 12796955
• Report Number: 2020664-2021-08070
• Device Sequence Number: 5143007
• Product Code: HQL
• UDI-Device Identifier: 05050474750722
• UDI-Public: (01)05050474750722(17)240309
• 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 Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/17/2021

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: 03/09/2024
• Device Model Number: DFR00V
• Device Catalogue Number: DFR00VU225
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/20/2021
• Supplement Date Received by Manufacturer: 11/22/2021
• Initial Report FDA Received Date: 11/11/2021
• Supplement Report FDA Received Date: 12/17/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/09/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female
• Patient Race: White