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

Model Number	AR40E
Medical Device Problem Code	Inaccurate Delivery (2339)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	11/11/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that while implanting the intraocular lens (iol), the lens got loaded and was advancing.The leading haptic and part of the lens went in; however, when the surgeon removed the injector half of the lens came out.The surgeon tried to push it in with kughlen hook, but it did not work.Then a back up iol was requested.There was a delay of 5 to 10 minutes and the incision was enlarged.Patient indicated that daily activities are significantly affected as it is hard to read.No other information was provided.
Additional Manufacturer Narrative
Age, weight, ethnicity: unknown/ not provided.Patient information cannot be provided due to personal data privacy legislation/policy if implanted, give date: not applicable, as lens was not implanted.Partially placed lens was removed within the initial surgery.If explanted, give date: not applicable, as lens was not implanted.Partially placed lens was removed within the initial surgery.Initial reporter telephone number: (b)(6).The device was not 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.(b)(4).All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
Additional information was received from the facility and the corresponding fields are updated in the report.Section a4: patient weight: (b)(4) lbs.Section a5: ethnicity/race: east asian, non hispanic.
Additional Manufacturer Narrative
Additional info: section d9: device available for evaluation? yes.Section d9: returned to manufacturer on: mar 14, 2023.Section h3: device evaluated by manufacturer¿ yes.Device evaluation: the complaint lens was received inside of a specimen vial.Visual inspection under magnification revealed that the complaint lens was received coated in viscoelastic residue.The lens was cleaned and, no issues were identified that could cause or contribute to the complaint issue.The complaint issue delivery issue was not confirmed.Conclusion: as a result of the investigation there is no indication of a product quality deficiency, and the reported issue could not be confirmed.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
Corrected data: upon further review it was noted that in the initial mdr section h6 component code 4755 was inadvertently not included; therefore, it is captured in this supplemental report.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
Corrected data: upon further review, it was noted that the account clarified they did not mention about the patient having having difficulty in reading.Therefore, this supplemental filing is to correct the comment in b5 it is hard to read.No additional information was provided.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: 15953321
• Report Number: 3012236936-2022-02925
• Device Sequence Number: 12597960
• Product Code: HQL
• UDI-Device Identifier: 05050474501874
• UDI-Public: (01)05050474501874(17)261030
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 05/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: AR40E
• Device Catalogue Number: AR40E00050
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/11/2022
• Supplement Date Received by Manufacturer: 02/08/2023; 03/28/2023; 04/18/2023; 04/29/2023
• Initial Report FDA Received Date: 12/09/2022
• Supplement Report FDA Received Date: 03/06/2023; 04/17/2023; 04/25/2023; 05/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/30/2021
• 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
• Patient Sex: Unknown
• Patient Weight: 131 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian