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

Model Number	AR40E
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	08/24/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the trailing haptic was broken.Issue was noted during implantation of a 3 piece intraocular lens (iol) into the patient's right eye.Iol lens was removed from the eye and patient was left aphakic.Incision was enlarged, vitrectomy was required, sutures were required, and medication was prescribed.There was a 40 minute delay in procedure.Patient status had been indicated as temporarily impaired.Vision pre-operative: 6/60 and vision post-operative: 6/18 +10.No further information provided.
Additional Manufacturer Narrative
Implant date: not applicable, as lens was removed/replaced in the initial surgery.Explant date: not applicable, as lens was removed/replaced in the initial surgery.Initial reporter telephone number: (b)(6).The device was not returning 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).Attempts were made to obtain additional information regarding the complaint; however, to date, no response has been received.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
Additional information: the surgeon provided information that vitrectomy that was required was not due to iol explant.The sutures during the explant were for incision enlargement.The medication prescribed were part of post surgery recovery standard of care medications.Patient has no other symptoms.No further information provided.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
• Manufacturer Contact: somyata nagpal ; 31 technology drive; irvine, CA 92618 ; 7142478552
• MDR Report Key: 15510204
• Report Number: 3012236936-2022-02493
• Device Sequence Number: 20262885
• Product Code: HQL
• UDI-Device Identifier: 05050474502079
• UDI-Public: (01)05050474502079(17)260312
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• 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: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/17/2022

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/12/2026
• Device Model Number: AR40E
• Device Catalogue Number: AR40E00185
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/30/2022
• Supplement Date Received by Manufacturer: 10/21/2022
• Initial Report FDA Received Date: 09/30/2022
• Supplement Report FDA Received Date: 11/17/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/11/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male