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

Model Number AR40E

Device Problem Inaccurate Delivery (2339)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 11/11/2022

Event Type  malfunction  

Event 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.

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.

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.

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.

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.

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
• Type of Device: 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
• MDR Text Key: 308010315
• Report Number: 3012236936-2022-02925
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 05050474501874
• UDI-Public: (01)05050474501874(17)261030
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: P980040
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 05/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/09/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 04/29/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/30/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Weight: 131 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian