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

Model Number AR40E

Device Problems Difficult to Insert (1316); Defective Component (2292)

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

Event Date 03/30/2021

Event Type  malfunction  

Manufacturer Narrative

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 Description

It was reported that the patient was diagnosed with aphakia in the left eye and mccannal suture pars plana approach procedure was booked.The suspect intraocular lens (iol) was inserted into patient's eye, however, did not stay in place due to lack of support as the haptics were too short.The lens was removed with no injury and replaced with another lens of different model.Additionally, a 10-0 nylon suture was used.No further information was available.

Manufacturer Narrative

Device evaluation: product testing could not be performed since the product was not returned for evaluation.Therefore, the reported issue could not be verified, and product quality deficiency could not be determined.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.

Manufacturer Narrative

Section d9: device available for evaluation? yes; section d9: returned to manufacturer on: june 8, 2021; section h3: device evaluated by manufacturer? yes.Device evaluation: the product was returned to the manufacturing site for evaluation.Visual inspection under magnification revealed, viscoelastic residue on the optic body and haptics.Which is consistent with a lens that was handled, during explant.The lens was cleaned, a scratch was observed, on the optic body.One haptic was detached, and the other haptic was damaged (bent).Due to the condition of the returned product, no further testing can be performed.Therefore, the complaint issue could not be confirmed.And no product deficiency could be identified.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
• 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: 11750154
• MDR Text Key: 264135045
• Report Number: 2648035-2021-07700
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 05050474502062
• UDI-Public: (01)05050474502062(17)210810
• Combination Product (y/n): N
• PMA/PMN Number: P980040
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup,Followup
• Report Date: 07/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/29/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/10/2021
• Device Model Number: AR40E
• Device Catalogue Number: AR40E00180
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/08/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/30/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 48 YR