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

Model Number DIB00

Device Problem Difficult to Insert (1316)

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

Event Date 12/13/2022

Event Type  Injury  

Manufacturer Narrative

Patient identifiers: information unknown/not provided.If implanted, give date: unknown/not reported: it is unknown if the iol had any patient contact or if it was implanted.If explanted, give date: unknown/not reported: it is unknown if the iol had any patient contact or if it was implanted.Device evaluation: the device was not returned at the manufacturing site; therefore, product testing could not be performed and the customer¿s reported complaint could not be verified.Manufacturing record review: the manufacturing records for the intraocular lens were reviewed.The product was manufactured according to specifications.A search of complaints related to this production order (po) was performed.The search of complaints revealed that no similar complaint for this production order number has been received.Conclusion: as a result of the investigation there is no indication of a product quality deficiency, and the reported issue could not be confirmed.Attempts have 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.

Event Description

It was reported that a patient with a weak cornea spot with an intraocular lens (iol) and the lens did not fit.A vitrectomy was required.Patient contact was reported as unknown.No further information was provided.

Manufacturer Narrative

Additional information: follow up information received that the suspect lens was not inserted, a back-up lens (b)(6), 22.0 diopter power was used instead, eye affected is right eye (od) health care professional surgeon is dr.(b)(6).Field below updated.Section e1: complaint reporter first name: (b)(6).Section e1: complaint reporter last name: (b)(6).Section e2: healthcare professional : yes section e3: occupation: physician.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: 16379589
• MDR Text Key: 309581392
• Report Number: 3012236936-2023-00348
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 05050474731813
• UDI-Public: (01)05050474731813(17)251026
• 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: 04/06/2023

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: DIB00U0225
• 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: 01/19/2023
• Initial Date FDA Received: 02/15/2023
• Supplement Dates Manufacturer Received: 03/27/2023
• Supplement Dates FDA Received: 04/06/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/26/2022
• 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