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

Model Number DIB00V

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

Patient Problems Vitreous Loss (2142); Capsular Bag Tear (2639); Zonular Dehiscence (2698); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 11/10/2022

Event Type  Injury  

Manufacturer Narrative

Age,weight : unknown; requested but not provided.If implanted, give date: not applicable, as lens was removed/replaced during the same procedure.If explanted, give date: not applicable, as lens was removed/replaced during the same procedure.Email address: unknown; requested but not provided.Telephone number:(b)(6).Device evaluation: product testing could not be performed since the product was not returned for evaluation as the lens 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.A search of complaints related to this production order (po) was performed.The search revealed that no additional complaints were received for this po.No escalation was required.Conclusion: a product deficiency has not been identified; therefore, no additional corrective actions have been initiated.(b)(4).This report is being filed on an international device; tecnis optiblue simplicity preloaded 1-piece iol, model dib00v that has a similar device, tecnis simplicity preloaded 1-piece iol model dib00 which is distributed in the unites states under pma (b)(4).Attempts were made to obtain the missing information; however, no response has been received.All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.

Event Description

It was reported that during implantation of the intraocular lens (iol), the lens protruded and ruptured the posterior capsule.The iol was deviated downwards immediately after surgery.The iol was removed to help clear vitreous in the anterior chamber.The zonules were damaged during the lens removal.An unplanned vitrectomy was performed.Another iol was implanted, model unknown.The surgery extended thirty minutes longer than planed to allow time for the additional procedures.Patient outcome is unknown.As a pre-existing condition, the patient is stated to have a narrow angle.The patient's uncorrected visual acuity (ucva) is 0.09 and best corrected visual acuity (bcva) is 0.4.The iol will not be returned for investigation as it was discarded.There was no reported device problem.No additional information was provided.

Manufacturer Narrative

Corrected data: upon further review, it was noted that section h6 was addressed inappropriately in the initial mdr report.Therefore, this supplemental filing is to correct section h6-type of investigation by adding codes 3331 and 4109.The following section has been updated accordingly: section h6-type of investigation: 3331 section h6-type of investigation: 4109 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: 15935406
• MDR Text Key: 305041542
• Report Number: 3012236936-2022-03004
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 05050474739567
• UDI-Public: (01)05050474739567(17)250314
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 12/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: DIB00V
• Device Catalogue Number: DIB00VI250
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/08/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/14/2022
• 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
• Patient Outcome(s): Required Intervention
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian