MAUDE Adverse Event Report: AMO PUERTO RICO MFG. INC. SENSAR IOL; INTRAOCULAR LENS

Model Number	AR40E
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Visual Impairment (2138)
Date of Event	07/06/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Section a, patient information: a2, a4, a5: information unknown/asku.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.
Event or Problem Description
It was reported the johnson and johnson (jnj) intraocular lens (iol) was explanted from the patient¿s right eye due to refractive surprise.Reportedly, the symptoms persisted between surgeries.The patient has fully recovered.No further information was provided.
Additional Manufacturer Narrative
Section d9: device available for evaluation? yes.Section d9: date returned to manufacturer: aug 14, 2023.Section h3: evaluated by manufacturer: yes.Device evaluation: the complaint lens was received inside of a lens case (serial# scratched off).No additional materials were received.Visual inspection under magnification revealed that the complaint lens was received cut in half and with a damaged haptic.The lens was cleaned and, no issues that could cause or contribute to the complaint issue could be identified.Based on the return condition of the lens, no further product 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.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

• Brand Name: SENSAR IOL
• 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: 17387148
• Report Number: 3012236936-2023-01912
• Device Sequence Number: 20363010
• Product Code: HQL
• UDI-Device Identifier: 05050474514133
• UDI-Public: (01)05050474514133(17)271002
• 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: 2023
• 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): 09/01/2023

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 Model Number: AR40E
• Device Catalogue Number: AR40E00095
• 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: 07/12/2023
• Supplement Date Received by Manufacturer: 08/25/2023
• Initial Report FDA Received Date: 07/25/2023
• Supplement Report FDA Received Date: 09/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/02/2022
• 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: Unknown