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

Model Number DIB00

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Discomfort (2330)

Event Type  Injury  

Event Description

It was reported that an intraocular lens (iol) was explanted from the patient's left eye due to patient being unhappy with results of sight from the iol.Patient unable to adapt to the iol.Visual concerns first identified in post-operative examination.Unplanned vitrectomy performed when explant occurred.The suspect iol was replaced with a different model lens (za9003) that has 1.5 diopter power difference (+21.5d).Patient has fully recovered.

Manufacturer Narrative

Date of event: unknown, not provided.The best estimate date is between 20 jan 2022 and 29 sep 2022.(b)(4).Product evaluation could not be performed because the product was not returned.The complaint issue reported could not be confirmed and no product deficiency could be identified.The manufacturing process record was evaluated and revealed that the product was manufactured and released according to specifications.A search of complaints related to this production order (po) was performed.The search revealed that no additional complaints were received for this po.As a result of the investigation there is no indication of a product quality deficiency and the reported issue could not be verified.Attempts have been made to obtain the missing information; however, no definitive response has been received.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Manufacturer Narrative

Section d9.Device available for evaluation? yes.Returned to manufacturer on: nov.21, 2022.Section h3.Device evaluated manufacturer? yes.Device evaluation: visual inspection under magnification revealed that the lens was cut into two pieces with both haptic detach and missing.Due to the returned condition of the lens, no further product evaluation could be performed.The complaint issues were not confirmed.The other observed issues during the product evaluation could not be confirmed to be related to a manufacturing or design issue.Conclusion: as a result of the investigation, there is no indication of a product deficiency or product malfunction.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: 15749633
• MDR Text Key: 303228803
• Report Number: 3012236936-2022-02627
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 05050474731752
• UDI-Public: (01)05050474731752(17)240620
• 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: 12/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/07/2022
• 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: DIB00U0200
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/16/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/20/2021
• 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 Outcome(s): Required Intervention
• Patient Age: 62 YR
• Patient Sex: Female