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

Model Number AR40E

Device Problem Contamination (1120)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/01/2022

Event Type  malfunction  

Event Description

It was reported that the intraocular lens (iol) had filmy substance causing lens to be dull.The surgeon could not remove the substance and asked for a new lens.The lens was removed and replaced during the same procedure.Another johnson and johnson iol was implanted as replacement (same model, same diopter).The issue was observed during a post-operative examination.Patient outcome was "no problems".No secondary surgery or medical intervention was required.No incision enlargement, suture, or vitrectomy was required.There was no delay in procedure.No further information was provided.

Manufacturer Narrative

If implanted, give date: not applicable, as lens was removed/replaced during the same procedure.If explanted, give date: not applicable, as lens was removed/replaced during the same procedure.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.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Manufacturer Narrative

Additional information: section d9: device available for evaluation? yes.Section d9: date returned to manufacturer: jan 04, 2023.Section h3: evaluated by manufacturer: yes.Device evaluation: visual inspection of the complaint lens revealed that it was received coated in a film, consistent with viscoelastic residue, and cut in half.Due to the presence of viscoelastic residue, it was difficult to identify the described film.Based on the customer description, the film on the lens was tested.The lens was sent to eag for fourier transform infrared (ftir) inspection.Per eag laboratories, the foreign substance tested is consistent with sodium hyaluronate (ophthalmic viscosurgical device (ovd)).The ftir spectrum raw data output file generated by eag laboratories was then compared against the añasco manufacturing process ftir library no results with at least a 0.90000 correlation.The top hit was ¿ovd evap¿ with a 0.888549 correlation.No additional matches were identified.No escalations are required due to ovd being used during the delivery.The complaint issue "dc-foreign material - loose" was not confirmed.The other observed issue found during the product evaluation could not be confirmed to be related to a manufacturing or design issue.Therefore, there is no indication of a product deficiency or product malfunction.Conclusion: as a result of the investigation there is no indication of a product quality deficiency, and the reported issue could not be verified.Corrected data: upon further review it was noted that "g4" field which should have been populated with "no" was inadvertently left blank on the initial mdr; therefore, the information has been corrected in this supplemental mdr report and the following fields have been updated accordingly: section g4: combination product: no.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: 16052409
• MDR Text Key: 308450314
• Report Number: 3012236936-2022-03197
• Device Sequence Number: 1
• Product Code: HQL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P980040
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 02/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2022
• 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: AR40E00205
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/02/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/29/2021
• 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 Sex: Male