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

Model Number DCB00

Device Problem Break (1069)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  malfunction  

Manufacturer Narrative

Date implanted: not applicable as the iol was not implanted.Date explanted: not applicable as the iol was not implanted.(b)(4).Attempts were made to contact the customer account requesting additional information regarding complaint however, to date no response has been received.Device evaluation: product evaluation could not be performed since, at the time of this investigation, the product had not been received.It was indicated the iol was discarded.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.No nc/er was found as part of the manufacturing record review.Historical data analysis: a search revealed that no other complaints have been received for this production order (po) number.Conclusion: based on the investigation results, there is no indication of a product malfunction or product quality deficiency.The reported issue was not verified.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Event Description

It was reported when inserting into the patient's operative eye, the pre-loaded intraocular lens (iol) was damaged as haptic was broken.There was no patient injury however, the incision was enlarged.Another lens with the same model and diopter size was used to complete the procedure.Iol was not available for return as it was discarded.No further information is available.

• 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 ; 31 technology drive; irvine, CA 92618 ; 7142478552
• MDR Report Key: 15966021
• MDR Text Key: 308084716
• Report Number: 3012236936-2022-03012
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 05050474636064
• UDI-Public: (01)05050474636064(17)250529
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 12/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: DCB00
• Device Catalogue Number: DCB0000190
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/17/2022
• Initial Date FDA Received: 12/13/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/29/2022
• 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