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

Model Number AR40M

Device Problem Scratched Material (3020)

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

Event Date 02/20/2024

Event Type  malfunction  

Manufacturer Narrative

Section a2, a4 and a5: unknown/ asked but not available.Section d6a: if implanted, give date: not applicable, as lens was removed/replaced in the initial surgery.Section d6b: if explanted, give date: not applicable, as lens was removed/replaced in the initial surgery.Section h3: other 81: 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.Attempts have been made to obtain missing information; however, to date, no response has been received.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Event Description

It was reported that when non preloaded intraocular lens (iol) was inserted into patient's eye it was noticed to be scratched.Lens was removed and replaced with backup lens in a secondary procedure.No other information is available.

Manufacturer Narrative

Corrected data: in review, it was observed that section "g2" should not have included "company representative" which inadvertently had been selected in the initial mdr report.In review, it was also noticed that the following fields inadvertently were left blank in the initial mdr report.Therefore, the information has been captured in this supplemental mdr report accordingly and as indicated below: section a3: gender: no information section g4: pma/510(k) number: p980040.This selection is no longer applicable to this event: section g2 report source added: company representative.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Manufacturer Narrative

Corrected data: in review, it was noticed that incorrect model (ar40e) and catalog number (ar40m00000-12) were inadvertently entered in the section "d4" of the initial mdr report; therefore, the information has been corrected in this supplemental mdr report as indicated below: section d4: model number: ar40m.Section d4: catalog number: ar40m00000.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
• MDR Report Key: 18924588
• MDR Text Key: 337912892
• Report Number: 3012236936-2024-00641
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 05050474501829
• UDI-Public: (01)05050474501829(17)280920
• 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,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 04/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: AR40M
• Device Catalogue Number: AR40M00000
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/22/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/20/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1