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

Model Number AAB00

Device Problems Break (1069); Defective Component (2292)

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

Event Date 08/03/2021

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.Initial reporter first name: unknown/ not provided.Device evaluation: product testing could not be performed since the product was not returned for evaluation.Therefore, the reported issue could not be verified.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 and the reported issue could not be verified.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Event Description

It was reported that a aab00 model intraocular lens(iol) had one haptic deformed, it was shorter than the normal size and thinned out toward the end.No loading issue or bent haptic reported.This event was observed after inserting lens into patient's left eye.The lens was removed and replaced with backup lens during the same procedure.There was no patient injury and no surgical/medical interventions were required.Patient was doing stable during post-op.No further information available.

Manufacturer Narrative

Section d9: device available for evaluation: yes.Section d9: returned to manufacturer on: sep 27, 2021.Device evaluation: visual inspection under magnification revealed that the lens was received cut in half and a haptic was observed to be visibly thinner moving away from the optic body.Dimensional inspection revealed that the lens haptics were within specifications at the base of the haptic, but the haptic was observed to be visibly thinner moving away from the optic body.Based on the return condition of the lens, no further product evaluation could be performed.The complaint issue could be confirmed.Manufacturing record review: the manufacturing process record was evaluated and revealed that there was no discrepancy and/or deviation found during the mrr (manufacturing record review).The units were released according to specification and in compliance with the product intended use as required.The manufacturing process contains the controls to identify and discard units with the reported issue.Per (b)(4) (process failure mode and effects analysis (pfmea) procedure, rev 02), this corresponds to a low risk.Therefore, no non-conformance/capa, escalation is not required.Additionally, 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 indication of a product quality deficiency, and the reported issue was verified.Failure investigation was completed.Based in the investigation, it can be determined that product did not meet specifications as the operators that performed visual inspection omitted to perform thorough inspection leading the reported issue.Awareness was conducted to the operators involved in the event to reinforce the importance of the visual inspection during the product inspection process and prevent reoccurrence.Johnson & johnson surgical vision will continue to monitor these types of complaints per (b)(4) (global complaint trending, revision 18).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
• Manufacturer Contact: somyata nagpal ; 1700 e st andrew place; santa ana, CA 92705 ; 7142478552
• MDR Report Key: 12389131
• MDR Text Key: 268935462
• Report Number: 2020664-2021-07248
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 05050474548473
• UDI-Public: (01)05050474548473(17)231211
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P980040
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/31/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/30/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/11/2023
• Device Model Number: AAB00
• Device Catalogue Number: AAB0000105
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/27/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/10/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/11/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: PLATINUM CARTRIDGE
• Patient Age: 73 YR
• Patient Sex: Male