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

Model Number AR40E

Device Problem Difficult to Insert (1316)

Patient Problem Capsular Bag Tear (2639)

Event Date 03/30/2021

Event Type  Injury  

Manufacturer Narrative

Weight, ethnicity: unknown, information not provided.Implant date (2020 reports): if implanted, give date: not applicable, as lens was removed/replaced in the initial surgery.Explant date (2020 reports): if explanted, give date: not applicable, as lens was removed/replaced in the initial surgery.(b)(6).All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Event Description

It was reported that there was capsular bag rupture followed by anterior vitrectomy.Doctor mentioned that the lens could not stay in place in sulcus.Issue was observed after implantation.Lens was fully inserted and removed during same procedure.Incision was enlarged, sutures were required, and there was delay in procedure.No other information provided.

Manufacturer Narrative

Device evaluation: product evaluation was not performed because the product has not been returned.The complaint issue reported could not be verified.Manufacturing records review: the manufacturing records for the device were reviewed.The product was manufactured and released according to specification.A search in complaint system revealed no additional complaint was received from this production order number.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.

• 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
• MDR Report Key: 11749858
• MDR Text Key: 255322193
• Report Number: 2648035-2021-07711
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 05050474502178
• UDI-Public: (01)05050474502178(17)230728
• Combination Product (y/n): N
• PMA/PMN Number: P980040
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 06/01/2021

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
• Device Operator: Health Professional
• Device Expiration Date: 07/28/2023
• Device Model Number: AR40E
• Device Catalogue Number: AR40E00235
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/31/2021
• Initial Date FDA Received: 04/29/2021
• Supplement Dates Manufacturer Received: 05/05/2021
• Supplement Dates FDA Received: 06/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention