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

Model Number	PCB00
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	Capsular Bag Tear (2639)
Date of Event	01/28/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the iol (intraocular lens) was implanted, but appeared to flip which caused a capsular rupture and required the vitrectomy probe to be used.Although the capsule was stable, the surgeon decided to remove the iol.It was decided not to implant another iol until the eye had settled.The lens was injected as normal and the surgeon was unsure why it had turned/ flipped.The lens was inserted and removed during same procedure.There was a 10 minute delay in the procedure.There was no incision enlargement or sutures required.The patient's post-operative outcome was not available.No further information is available.
Additional Manufacturer Narrative
Age, weight and ethnicity: per eu regulation (b)(4) (general data protection regulation), patient identifiers were not collected or recorded and therefore are not available.If implanted; give date: n/a (not applicable).The intraocular lens was inserted and removed during the same procedure.If explanted; give date: n/a (not applicable).The intraocular lens was inserted and removed during the same procedure.(b)(6).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 evaluation: the manufacturing records for the intraocular lens were reviewed.The product was manufactured according to specifications.The search 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.All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.

• Brand Name: TECNIS IOL
• Common Device Name: 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: 13564585
• Report Number: 3012236936-2022-00447
• Device Sequence Number: 5848715
• Product Code: HQL
• UDI-Device Identifier: 05050474558489
• UDI-Public: (01)05050474558489(17)231130
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/18/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 11/30/2023
• Device Model Number: PCB00
• Device Catalogue Number: PCB0000310
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/28/2022
• Initial Report FDA Received Date: 02/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/30/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown