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

Model Number DIB00

Device Problem Physical Resistance/Sticking (4012)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

Age, weight, ethnicity: information unknown/not provided.Date of event: unknown/not provided.Catalog number: a complete catalog number is unknown, as the serial number was not provided.Serial number: unknown, as information was not provided.Expiration date: unknown, as the serial number was not provided.Udi number: unknown, as the serial number was not provided.If implanted; give date: unknown/not provided.If explanted; give date: n/a (not applicable).The lens remains implanted.Device manufacture date: unknown, as the serial number was not provided.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 record could not be reviewed since the serial number was not provided.Conclusion: the complaint product was not returned, and serial number is unknown, it is not possible to determine a malfunction and/or product quality deficiency.Attempts have been made to obtain missing information; however, the account did not have the information.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Event Description

It was reported that an intraocular lens (iol) haptic was sticking when loading.Through follow-up, it was learned there were two dib00s where haptics were sticking, but they were able to implant the lenses.It was not known what the haptics were sticking to.Through further follow-up, it was learned that there are about 10-15 of the dib00 iols.The exact number of iols or serial numbers are unknown.The scrub technicians said the haptics were sticking together, almost like they are holding hands.This was noticed once the iol has been inserted into the patients operative eye.The surgeon then unsticks them with something like a utrada and the iol remains implanted in the patients eye.There were no unplanned sutures/vitrectomies/enlarged incisions required.No patient injuries have been reported.The products are not available for return as they were implanted into the patients eye.No other information is available.This report is for the approximate 10-15 dib00s implanted where exact number of iols and serial numbers were unknown.Separate reports are being submitted for the other dib00 models.

• 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: 15794991
• MDR Text Key: 307908463
• Report Number: 3012236936-2022-02846
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Public: (01)
• 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: Nurse
• Type of Report: Initial
• Report Date: 11/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/14/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: DIB00
• Device Catalogue Number: UNK-DIB00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/25/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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