MAUDE Adverse Event Report: AMO PUERTO RICO MFG. INC. POSTERIOR-CHAMBER INTRAOCULAR LENS, PSEUDOPHAKIC

Model Number	DFR00V
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Blurred Vision (2137); Halo (2227)
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient had intraocular lens implanted and complained of blurry vision overall, halos and poor vision, especially at night and was not happy with their visual outcome.The doctor recommended a contact lens to see if that improved their vision but the results were negligible.Last manifest refraction prior to the exchange was -1.00 +0.50 x 178 with a best corrected distance vision of 20/25.Patient decided to have the iol exchanged.There were no other complications such as capsule tear, vitrectomy, sutures or incision enlargement.The iol was explanted and replaced with a non jnj lens, model rxsight light adjustable iol.Reportedly, the explanted iol will be returned.No further information was provided.
Additional Manufacturer Narrative
Section a, patient information: a2, a4, a5: information unknown/asku.Section b3 date of event: the exact date is unknown.The best estimate is between the implant and explant dates, (b)(6) 2022 and (b)(6) 2023 respectively.Section h3-other (81): the device has not been returned for evaluation.Therefore, a failure 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 have been made to obtain the missing information; however, to date, no response has been received.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: may 22, 2023.Section h3: evaluated by manufacturer: yes.Device evaluation: the lens was received.Visual inspection under magnification revealed that the lens was received cut in half with no further cosmetic defects before and after cleaning.No defects that could contribute to visual issues were observed.Based on the returned condition of the lens no further evaluation could be performed.Conclusion: as a result of the investigation there is no indication of a product quality deficiency, and the reported issue could not be verified.Please note that the information reported in sections d2 (common device name), h.6 (health effect -clinical code and medical device problem code) and section g.1 (manufacturer contact e-mail) is information that remains unchanged from the initial emdr report.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

• Brand Name: POSTERIOR-CHAMBER INTRAOCULAR LENS, PSEUDOPHAKIC
• Common Device Name: INTRAOCULAR LENS
• 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: 16915926
• Report Number: 3012236936-2023-01029
• Device Sequence Number: 2161769
• Product Code: HQL
• UDI-Device Identifier: 05050474750739
• UDI-Public: (01)05050474750739(17)241019
• 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: 2022
• Device Explanted Year: 2023
• 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): 06/14/2023

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: 10/19/2024
• Device Model Number: DFR00V
• Device Catalogue Number: DFR00VU230
• 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: 04/21/2023
• Supplement Date Received by Manufacturer: 06/07/2023
• Initial Report FDA Received Date: 05/11/2023
• Supplement Report FDA Received Date: 06/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/19/2021
• 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