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

Model Number DIB00

Device Problems Difficult to Insert (1316); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Capsular Bag Tear (2639); Zonular Dehiscence (2698)

Event Date 08/08/2022

Event Type  Injury  

Event Description

It was reported that the customer put the intraocular lens (iol)in the patient's left eye but patient's eye would not hold it.They had to cut the iol in half to take it out and replaced it with a non johnson and johnson iol.It was learned that during the procedure there was a capsular weakness which lead to a posterior capsular tear.However, the customer did not think that there was a product quality issue.There was no incision enlargement, no vitrectomy or sutures done.The patient left without problems.No other information was provided.

Manufacturer Narrative

Unknown/ not provided.If implanted, give date: not applicable, as lens was not implanted if explanted, give date: not applicable, as lens was not implanted hence not removed.Other: the device is not returned; therefore, a failure analysis of the complaint device cannot be completed.A review of the device record and complaint trending for this device will be performed.Upon completion of the review, if there is any further relevant information a supplemental medwatch will be filed.An attempt has been made to obtain missing information; however, no definitive response has been received.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Manufacturer Narrative

Corrected data; upon further review it was noted that device code of 1316 (difficult to insert) is not accurate.Rather it should be 2993 (adverse event without identified device or use problem).Also, 2698 (2698 - zonular dehiscence) is added to h6: health effect - clinical code.Additional information: section d9.Device available for evaluation?: yes.Returned to manufacturer on: sep.8, 2022.Section h3.Device evaluated manufacturer?: yes.Device evaluation: the complaint lens was received stuck to a plastic tray.Visual inspection under magnification revealed that the complaint lens was received cut in half.The lens was cleaned and, no issues that could contribute to complaint report were identified.Based on the return condition of the lens, no further product evaluation could be performed.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: 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: 15255775
• MDR Text Key: 298197611
• Report Number: 3012236936-2022-02223
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 05050474731912
• UDI-Public: (01)05050474731912(17)240815
• 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: 10/04/2022

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 Model Number: DIB00
• Device Catalogue Number: DIB00U0275
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/17/2022
• Initial Date FDA Received: 08/18/2022
• Supplement Dates Manufacturer Received: 09/30/2022
• Supplement Dates FDA Received: 10/04/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/15/2021
• 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
• Patient Age: 68 YR
• Patient Sex: Female