MAUDE Adverse Event Report: AMO PUERTO RICO MFG. INC. TECNIS IOL; LENS, MULTIFOCAL INTRAOCULAR

Model Number	DFR00V
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Blurred Vision (2137)
Date of Event	12/19/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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 in a secondary procedure from the patient's left eye due to blurry vision.Initial opening of the original temporal primary corneal incision, significant intraoperative floppy iris syndrome with iris prolapse that required closing this primary incision with 10-0 nylon sutures, creation of a second superior primary corneal incision with slight enlargement for lens explant with subsequent 10-0 nylon suture closure.It was confirmed it had nothing to do with the product.A vitrectomy was not required.Another johnson & johnson lens, model za9003 22.0 diopter was implanted as a replacement.Patient outcome reported as still healing from surgery.Last visit, visual acuity 20/100 with residual corneal folds and anterior chamber reaction, pending suture removal at follow up in 2 weeks.No other information was provided.
Additional Manufacturer Narrative
Corrected data: upon further review, it was discovered that 1st supplemental report submitted needed correction on some information.These are the following: 1.Section d9: device availability section was inadvertently filled out as "device available for evaluation - yes", also "returned to manufacturer -box, checked", "date returned to manufacturer - feb.28, 2023".This sections should have been left blank during 1st supplemental report submission, as they have already been indicated in the initial report submitted.2.Section h6: product investigation findings needs to have code 114 (operational problem identified) added.3.Section h6: investigation conclusion code should have been 4315 (cause not established) instead of 67 (no problem detected).This report is being submitted for correction of information submitted during 1st supplemental report submission.The following fields have been updated: section h6: investigation findings: 114.Section h6: investigation conclusion: 4315.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
Section d9.Device available for evaluation? yes.Returned to manufacturer on: feb.28, 2023.Section h3.Device evaluated manufacturer? yes.Device evaluation: the suspect iol was cut in half and with an edge chip.No further issues were identified.The complaint issues; explant, burry vision and sutures were not identified during product evaluation.The other observed issues during the product evaluation could not be confirmed to be related to a manufacturing or design issue.Therefore, there is no indication of a product deficiency or product malfunction.Manufacturing record review: the manufacturing process record was evaluated and revealed that the product was manufactured and released according to specifications.A search revealed that no other complaints were received from this production order.Conclusion: as a result of the investigation, there is no indication of a product deficiency or product malfunction.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

• Brand Name: TECNIS IOL
• Common Device Name: LENS, MULTIFOCAL INTRAOCULAR
• Manufacturer (Section D): AMO PUERTO RICO MFG. INC.; road 402 north, anasco ind. pk; anasco PR 00610
• Manufacturer Contact: somyata nagpal ; 31 technology drive; irvine, CA 92618 ; 7142478552
• MDR Report Key: 16475655
• Report Number: 3012236936-2023-00377
• Device Sequence Number: 3150332
• Product Code: MFK
• UDI-Device Identifier: 05050474750739
• UDI-Public: (01)05050474750739(17)240823
• Combination Product (Y/N): N
• Initial Reporter State: DE
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2023
• 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): 03/22/2023

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: 08/23/2024
• Device Model Number: DFR00V
• Device Catalogue Number: DFR00VU230
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/28/2023
• 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: 02/03/2023
• Supplement Date Received by Manufacturer: 03/15/2023; 03/22/2023
• Initial Report FDA Received Date: 03/02/2023
• Supplement Report FDA Received Date: 03/15/2023; 03/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/23/2021
• 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 Age: 72 YR
• Patient Sex: Female
• Patient Weight: 90 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White