MAUDE Adverse Event Report: AMO PUERTO RICO MFG. INC. TECNIS SIMPLICITY; INTRAOCULAR LENS

Model Number DIB00

Device Problems Delivered as Unsterile Product (1421); Manufacturing, Packaging or Shipping Problem (2975)

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

Event Date 08/31/2021

Event Type  malfunction  

Manufacturer Narrative

Age or date of birth, weight and ethnicity: unknown, information not provided.If implanted, give date: not applicable, as there is no indication that the lens was implanted if explanted, give date: not applicable, as there is no indication that the lens was implanted; therefore, not explanted.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Event Description

It was reported that the intraocular lens outer box was sealed but the actual lens peal pack was only partially sealed.There was no patient contact.The event was observed upon opening the package.No further information was available.

Manufacturer Narrative

Section d9: device available for evaluation: yes.Section d9: returned to manufacturer on: nov 30, 2021.Section h3: device evaluated by manufacturer: yes.Device evaluation: the product was returned to the manufacturing site for evaluation.Visual inspection performed revealed that the supplier sealed area was partially opened and the unit was not used.Upon evaluation of the complaint product the supplier sealed side looked uniform.There were no holes, voids, discontinuities, or wrinkles observed in the supplier sealed side.No defect was identified that could cause the reported problem.The complaint issue could not be confirmed and based on the investigation results it could not be determined if the reported issue is of manufacturing and/or supplier related.Through a communication with the supplier, it was indicated that the results of the peel strength test were within the validation parameters (1.0 lbs/in.Min.).They stated that the lowest tensile value was 2.06 lbs/in.Based in the evaluation incoming and manufacturing processes contains the controls to identify and discard units with this type of complaint.Manufacturing record review: the manufacturing records for the intraocular lens were reviewed.The product was manufactured and released according to specification.The search revealed one additional investigation request (ir) for this production order number has been received, however, no product deficiency was 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: TECNIS SIMPLICITY
• 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: 12545038
• MDR Text Key: 273770989
• Report Number: 2020664-2021-07561
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 05050474731745
• UDI-Public: (01)05050474731745(17)240318
• 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,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 02/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/18/2024
• Device Model Number: DIB00
• Device Catalogue Number: DIB00U0195
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/30/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/28/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/18/2021
• 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