MAUDE Adverse Event Report: AMO PUERTO RICO MFG. INC. AR40E; INTRAOCULAR LENS

Model Number AR40E

Device Problems Material Fragmentation (1261); Scratched Material (3020)

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

Event Type  malfunction  

Event Description

It was reported that when the non preloaded intraocular lens was inserted in to the patient's eye a scratch was observed across the middle of the lens and the trailing haptic was missing.Haptic was observed in the cartridge.Lens was removed from the eye and replaced with same model lens with +25.5d.There was no harm to the patient.Healon pro was used for lens loading.It was allowed to come to room temperature before use.There are no plans to do any additional procedures in the future.No other information is available.

Manufacturer Narrative

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.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Manufacturer Narrative

Corrected information: in the report submitted feb 16, 2024 ((b)(4)), an incorrect catalog number was inadvertently submitted.This report contains the corrected catalog number.Section d4 - catalog #: ar40e00255.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

• Brand Name: AR40E
• 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: 18723191
• MDR Text Key: 335600905
• Report Number: 3012236936-2024-00408
• Device Sequence Number: 1
• Product Code: HQL
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/01/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2024
• 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: AR40E00255
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/03/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/06/2023
• 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 Age: 76 YR
• Patient Sex: Male
• Patient Ethnicity: Hispanic
• Patient Race: American Indian Or Alaskan Native