MAUDE Adverse Event Report: AMO MANUFACTURING NETHERLANDS TECNIS IOL; EXTENDED DEPTH OF FOCUS IOL

Model Number	DFW225
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Eye Injury (1845); Visual Impairment (2138); Capsular Bag Tear (2639)
Date of Event	09/09/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Age or date of birth, weight, and ethnicity: unknown, not provided.Date of event is unknown.The best estimate time would be between (b)(6) 2021.Attempts have 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 the tecnis synergy preloaded intraocular lens (iol) was explanted from the patient's operative eye.The reason for the explant is unknown/not provided.No additional surgical intervention performed.The patient outcome post-surgery was not provided.No additional information was provided.
Additional Manufacturer Narrative
Upon further review the following information was received prior to initial emdr submission and inadvertently not included in the initial submission.The following has been updated accordingly: date of birth: 17-mar-1943.Patient weight: 190 pounds.Date of event: (b)(6) 2021 describe event or problem: through follow-up additional information was received clarifying the intraocular lens (iol) was explanted from the patient¿s ocular dexter (right eye) because of double vision and capsule tear during first iol implantation surgery that caused iol to be off center; capsule tear occurred while doctor was phacoing.Iol was replaced with a different model lens with a different diopter size, za9003 17.0 diopter.The incision was enlarged, there was unplanned vitrectomy, unplanned 10-0 nylon suture, and unplanned miochol was used, miochol was part of the doctor's standard care.Patient outcome post-operatively was reported as great.No further information is available.Health effect - impact code: 4625 sutures.Health effect - impact code: 4625 vitrectomy.Health effect - impact code: 4644 medication required.Health effect - clinical code: 2639 - capsular bag tear.Health effect - clinical code: 2138 - visual impairment (diplopia).All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
Through follow-up additional information was received clarifying the intraocular lens (iol) was explanted from the patient¿s ocular dexter (right eye) because of double vision and capsule tear during first iol implantation surgery that caused iol to be off center; capsule tear occurred while doctor was phacoing.Iol was replaced with a different model lens with a different diopter size, za9003 17.0 diopter.The incision was enlarged, there was unplanned vitrectomy, unplanned 10-0 nylon suture, and unplanned miochol was used, miochol was part of the doctor's standard care.
Additional Manufacturer Narrative
Product investigation was received, and the following fields were updated accordingly: section d-9: device available for evaluation: yes.Section d-9: date returned to manufacturer: 09-dec-2021.Section h-3: device evaluated by manufacturer: yes.Device evaluation: visual inspection under magnification revealed that the lens was cut in half (with one half missing), which is consistent with a lens that was handled during explant.Based on the return condition of the lens, no further product evaluation could be performed.The complaint issue could not be confirmed, and no product deficiency could be identified.Manufacturing records review: the manufacturing records for the product were reviewed, the product was manufactured and released according to specification.No nc/er was found as part of this manufacturing records review.Historical data analysis: a search revealed that no other complaints have been received for this production order (po) number.Conclusion: as a result of the investigation, there is no indication of a product malfunction or product quality deficiency.The reported issue was not verified.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

• Brand Name: TECNIS IOL
• Common Device Name: EXTENDED DEPTH OF FOCUS IOL
• 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: 12669485
• Report Number: 2020664-2021-07660
• Device Sequence Number: 13760874
• Product Code: MFK
• UDI-Device Identifier: 05050474751835
• UDI-Public: (01)05050474751835(17)240312
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/14/2022

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: 03/12/2024
• Device Model Number: DFW225
• Device Catalogue Number: DFW225U190
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/09/2021
• 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: 09/23/2021
• Supplement Date Received by Manufacturer: 10/19/2021; 01/07/2022
• Initial Report FDA Received Date: 10/20/2021
• Supplement Report FDA Received Date: 11/06/2021; 01/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/12/2021
• 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: Male
• Patient Weight: 86 KG