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

Model Number	DFW150
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Blurred Vision (2137)
Date of Event	02/28/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device has not returned for evaluation.Therefore, a visual analysis of the complaint device cannot be completed.A review of the device history record, complaint trending, and risk documentation for this device will be performed.Upon completion of the review, if there is any further relevant information a supplemental medwatch will be filed.Attempts were made to obtain the missing information, however, the customer did not provide it.All pertinent information available to johnson & johnson surgical vision, inc., has been submitted.
Event or Problem Description
Customer reported that after implanting a johnson & johnson (jnj) intraocular lens (iol) into the patient's right eye, they experienced blurry vision.The patient complaint about blurry vision in their right eye, vision in two eyes does not match.The iol was explanted from their right eye.The customer explained that they did not have a jnj iol in stock so they went with a different manufacturer.The patient's left eye is fine and there are no issues with that eye.It was indicated that there were no complications such as capsule tear, vitrectomy, sutures or medications outside the regular standard of care with the initial implanted lens.No further information was provided.
Additional Manufacturer Narrative
Corrected data: upon further review, it was noted that in the initial mdr report, inadvertently, the date "feb 28, 2022" was entered in section "g3" which is incorrect.The correct date is mar 03, 2022.Therefore, this follow-up #2 is being submitted to provide the corrected data.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
Section d9: device available for evaluation? yes.Section d9: date returned to manufacturer: mar 22, 2022.Section h3: evaluated by manufacturer: yes.Device evaluation: visual inspection under magnification revealed that the lens was received cut into three pieces.No issues related to or could have contributed to visual issues were observed.Based on the return condition of the lens (cut into three pieces) no further product evaluation could be performed on the lens.A product quality deficiency could not be determined.Manufacturing record review: the manufacturing records for the product were reviewed.The product was manufactured and released according to specifications.A search of complaints related to this production order (po) was performed.The search revealed that no other complaints were received for this po.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: 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: 13691637
• Report Number: 3012236936-2022-00582
• Device Sequence Number: 5046454
• Product Code: MFK
• UDI-Device Identifier: 05050474751293
• UDI-Public: (01)05050474751293(17)241129
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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: 2022
• 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): 06/27/2022

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: 11/29/2024
• Device Model Number: DFW150
• Device Catalogue Number: DFW150U215
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 02/28/2022
• Supplement Date Received by Manufacturer: 05/13/2022; 06/27/2022
• Initial Report FDA Received Date: 03/08/2022
• Supplement Report FDA Received Date: 05/20/2022; 06/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/29/2021
• 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