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

Model Number	AR40E
Medical Device Problem Code	Material Opacification (1426)
Health Effect - Clinical Code	Visual Impairment (2138)
Date of Event	09/30/2015
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Section a2, a4 and a5: unknown/not provided, as information was asked but it was not provided.Section b3: date of event: (b)(6) 2015 - this is an estimate date.Section d6a: if implanted, give date: exact date is unknown.Customer provided implant date as (b)(6) 2015.Section d6b: if explanted, give date: not applicable, as lens remains implanted.Section e1: initial reporter's: telephone number: (b)(6) device evaluation: product evaluation was not performed because the product has not been returned.Customer provided photographs for evaluation.The photographs showed a dark field technique segment slit lamp picture of an pseudophakic eye.General cloudiness/haziness can be observed in the pupillary area.No other details can be observed/described.The root-cause and clinical impact of the observed phenomena could not be determined from a picture assessment.Manufacturing record review: the manufacturing records for the product were reviewed.The product was manufactured and released according to specification.A search of complaints related to this production order (po) was performed.The search revealed that no other complaints have been received for this po.Conclusion: as a result of the investigation there is no indication of a product quality deficiency and the reported issue could not be verified.All pertinent information available to johnson & johnson surgical vision, inc has been submitted.
Event or Problem Description
The physician reported that a patient of his who underwent implantation surgery in (b)(6) 2015, presented with opacification of the ar40e (3pc sensar, acrylic square edge lens) intraocular lens (iol).The patient is doing well and has a good visual acuity (va), 20/20 ¿ 20/30 not being an indication for an explant.Per follow-up, at the time the complaint was reported, the patient's va was fine, patient was only bothered by the opacification of the iol.So, the physician decided to monitor the case.However, during a post-operative visit, the patient has a 20/60, 20/200 va and the doctor intends to explant the lens in 1 or 2 months, as the patient is complaining.No further information provided.

• 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: 16907628
• Report Number: 3012236936-2023-01193
• Device Sequence Number: 14827052
• Product Code: HQL
• UDI-Device Identifier: 05050474502079
• UDI-Public: (01)05050474502079(17)190301
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/10/2023

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: 03/01/2019
• 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: 04/18/2023
• Initial Report FDA Received Date: 05/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2014
• 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
• Patient Sex: Unknown