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

Model Number	AR40E
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Capsular Bag Tear (2639)
Date of Event	07/13/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Unknown, information not provided.If implanted, give date: not applicable, as lens was removed/replaced in the initial surgery.If explanted, give date: not applicable, as lens was removed/replaced in the initial surgery.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that the intraocular lens (iol), model ar40e, was removed and replaced from the patient's left eye during the same procedure due to capsule tear.A competitor lens was implanted as the replacement.Account provided that the outcome did not significantly interfere with the patient's daily life activities.No further information available.
Additional Manufacturer Narrative
Device evaluation: the original folding carton, patient stickers, implant id card, and patient id card were received, however, no complaint lens was received, and therefore no product evaluation could be performed on the lens.The complaint issue could not be confirmed, and no product deficiency could be identified.Manufacturing records review: the manufacturing records for the product were reviewed.The product was manufactured and released according to specification.A search revealed that no additional complaint was received from this production order.Conclusion: as a result of the investigation, there is no indication of a product quality deficiency.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
• MDR Report Key: 12478551
• Report Number: 2020664-2021-07385
• Device Sequence Number: 14397890
• Product Code: HQL
• UDI-Device Identifier: 05050474502154
• UDI-Public: (01)05050474502154(17)240810
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• 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: distributor,health profession
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 08/10/2024
• Device Model Number: AR40E
• Device Catalogue Number: AR40E00225
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 08/19/2021
• Supplement Date Received by Manufacturer: 10/25/2021
• Initial Report FDA Received Date: 09/15/2021
• Supplement Report FDA Received Date: 11/03/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: EMERALD SHOOTER
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 73 YR